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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study than current guidelines, but well documented method and results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Test methodology predates OECD 405, but is similar in scope/method.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot #TPPx-Z18-04080A (Borg Warner)

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of each animal served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 2, 3, 5, and 7 days post exposure.
Number of animals or in vitro replicates:
6
Details on study design:
0.1 mL applied to the right eye of 6 health young adult albino rabbits. The test article was not washed from the eyes. The left eye of each of the 6 rabbits served as the control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
6
Max. score:
8
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: days 1-7 post exposure
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: days 1-7 post exposure
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: no effect
Irritant / corrosive response data:
No results on any parameters 5-7 days post exposure.

Individual animal data provided in attached table.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Mean conjunctivae results were 6.0 after 24 hours, 3.7 after 48 hours, 1.3 after 72 hours and 0.0 after 5 and 7 days. Reactions were observed in 6 of 6 animals at 24 hours, 6 of 6 animal at 48 hrs, and 3 of 6 animals at 72 hours. The authors concluded that TPP is not a primary ocular irritant, though this conclusion does not appear to be consistent with current EU and U.S. CPSC regulations. TPP is classified as an eye irritant.
Executive summary:

TPP is classified as an eye irritation under the existing EU (ATP) regulations. This study indicates that while TPP can cause irritation to the eye, the effects diminish greatly after 24 -48 hours and fully reversible within 5 days for all animals.