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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
GLP was not implemented at the date of study conduct.

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
EC Number:
259-226-5
EC Name:
Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
Cas Number:
54553-91-2
Molecular formula:
C10H6O8.2C9H10N2
IUPAC Name:
benzene-1,2,4,5-tetracarboxylic acid - 2-phenyl-4,5-dihydro-1H-imidazole (1:2)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.6 - 5.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: paraffin oil
Controls:
other: animals were their own control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h exposure
Observation period:
10 days
Number of animals:
6 (3 male and 3 female)
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g wetted with paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 10 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch removal; evaluation based on readings 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.28
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
1.25
Max. score:
8
Reversibility:
fully reversible within: 10d
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.17
- irritation index: 1.25/8
Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch removal
evaluation based on readings 1-4

REVERSIBILITY: complete within 10 days
OTHER EFFECTS: eschar formation in the males (day 7)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classification : not irritating

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