211(b) Toxicology Research Group Gasoline TBA VC:

In Vivo Micronucleus Assay

Reviewer Checklist 

1

Comments Action/Response Page

EPA

No comments Agreed.

Peer Reviewer – Goldsworthy

This study was properly conducted and scientifically 

sound. Positive and negative controls performed as 

expected and within historical range. G-TBA did not 

cause any significant increases in the incidence of 

micronucleated mature erythrocytes and did not cause 

any decreases in the proportion of immature 

erythrocytes. No evidence of bone marrow toxicity was 

observed. I concur with the report conclusions. 

Agreed.

Peer Reviewer – Schlesinger

The data presented support the conclusion. Agreed.

p.ll. Replace "?" in first paragraph with appropriate 

dates. 

The term "negative control"is used interchangeably 

with "air control." The investigators should use just one 

term forthis group.

Dates for inclusion entered as 

provided overleaf (7/26 and 

8/21/01).

Terminology unchanged in line 

with previous reports.

OK

p.1096

p.13. The material presented under the "Deviations 

from Protocol" banner are not

deviations from protocol, unless they really do 

represent changes from the originally

submitted study design.

Deviations entered as they are 

not present within the final 

protocol. Validity statement 

entered.

OK

p. 1098

211(b) Research Group Reviewer

Please add a table of male and female data separately 

as was done for the second draft of the Gasoline 

study.

This was not a pre-requisite for 

previous API studies.

OK

Table 1, p. 19: Is the % ie/ie+me calculated from the 

ratio of total values within each group or as a mean 

of the summed % for individual animals? The 

method makes a slight difference in the 

20000mg/m3value since the ratio calculated from 

total values is 45.6 rounded to 46 as stated in the 

table or the average of summed % from individual 

animals is 45.4, rounded to 45. Please check (Also 

cited by QA).

Data unchanged as 46, once 

rounded from 45.55. 

Calculated from total values 

using more accurate values.

OK

Conclusions: Suggest the addition of “of either sex” 

to the conclusion that no significant increases ...were 

observed in rats of either sex treated with Gasoline 

TBA vapor condensate.

Entered, as requested.

OK

p. 1100
211(b) Toxicology Research Group Gasoline TBA VC:

In Vivo Micronucleus Assay

Reviewer Checklist 

2

Comments Action/Response Page

211(b) Research Group QA/QC Reviewer

1. Satellite Procedure Report – Rat 

Micronucleus Test. The ERC Quality 

Assurance Statement for this report does 

not indicate a date on which the report was 

sent to the Study Director and Test Facility 

Management. Per GLPs, QA inspection 

and audit reports are to be given to the 

Study Director and Management. Dates of 

this reporting need to be included. 

Not entered, as per previous 

studies. This does not require 

reporting, only to be performed, 

and confirmation that 

Management and the required 

personnel are informed.

Ok

2. Satellite Procedure Report – Rat 

Micronucleus Test. Page 11: Dates need 

to be filled in for the first sentence. (7/26 

and 8/21/01).

Dates entered. Ok

3. Satellite Procedure Report – Rat 

Micronucleus Test. Page 10: The last 

sentence indicates the experimental start 

and completion dates for the slide 

evaluation phase of the test. Since the 

GLPs have specific definitions for 

“experimental start date” and it does not 

mean slide evaluation, maybe another term 

would be better. 

Report clearly states the dates 

for actual timelines for the inlife phases and the slide 

analysis phase. No change 

necessary.

OK

4. Satellite Procedure Report – Rat 

Micronucleus Test. Page 13: The 

deviations to protocol are listed but give no 

potential affect on the study. This should 

be indicated. 

Validity statement entered for 

clarity of study conduct.

Ok

5. Satellite Procedure Report – Rat 

Micronucleus Test. Page 19, Table 1, 

20,000 mg/m3 Proportion of ie, please 

verify this mean to be 46. Means may be 

calculated with more significant figures 

that are present in this report. 

Left as 46, thus using more 

significant figures in 

calculation.

Ok