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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The potential of RC9927 to cause damage to the conjunctivae, iris or cornea was assessed in 3 male and 3 female New Zealand White rabbits, each subject to single ocular instillation of 0.1 ml of the test material. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment according to Draize.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) tetrabromophthalate
EC Number:
247-426-5
EC Name:
Bis(2-ethylhexyl) tetrabromophthalate
Cas Number:
26040-51-7
Molecular formula:
C24H34Br4O4
IUPAC Name:
1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate
Test material form:
liquid
Details on test material:
RC 9927 (batch 6159-199-3), also identified as FR-45B, a slightly turbid, viscous pale yellow liquid received from Pennwalt Corporation on 1st September 1986.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
72 hours (no information if eyes were washed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male and 3 female animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable, score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable, score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score = 0 at any time point

Any other information on results incl. tables

A crimson-red appearance to the conjunctiva or slight injection of the conjunctival blood vessels and an ocular discharge, were observed among the rabbits one hour after instillation of RC9927. No other change was apparent. All ocular irritation responses had resolved by the 24-hour examination.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The potential of RC9927 to cause damage to the conjunctivae, iris or corneawas assessed in 3 male and 3 female New Zealand White rabbits, each subject to single ocular instillation of 0.1 ml of the test material. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment according to Draize.

A crimson-red appearance to the conjunctiva or slight injection of the conjunctival blood vessels and an ocular discharge, were

observed among the rabbi ts one hour after instillation of RC9927. No other change was apparent. All ocular irritation responses had resolved by the 24-hour examination.

Under the conditions of this test, RC9927 was not irritating to the eye.