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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the test material to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessed according to Draize 1, 24, 48 and 72 hours after removal of the dressings.
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

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, score = 0 at any time point

Any other information on results incl. tables

Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent.

all dermal irritation responses had resolved by the 48 -hour examination.

The control sites did not show any response to the control procedure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the testmaterial to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessedaccording to Draize 1, 24, 48 and 72 hours after removal of the dressings.

Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent. All dermal irritation responses had resolved by the 48 -hour examination.

The control sites did not show any response to the control procedure.

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