Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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.

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

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

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)

Interpretation of results:

GHS criteria not met

Conclusions:

Classification : not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Remarks:

GLP was not implemented at the time of study conduct.

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g of 100% substance

Duration of treatment / exposure:

72h not rinsed

Observation period (in vivo):

6d

Number of animals or in vitro replicates:

6 (3 male, 3 female)

Details on study design:

TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 4.0 - 5.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
ADMINISTRATION/EXPOSURE
- Postexposure observation period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data
sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual
inspections

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

110

Reversibility:

fully reversible within: 72h

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 72h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.33
- Conjunctivae (Chemosis): 0
- Overall irritation score: 1.67/110
REVERSIBILITY: complete within 72 hours

Interpretation of results:

GHS criteria not met

Conclusions:

Test Item is considered not irritating based to the availabel data according to OECD405 in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

No reasons for classification (only limited effects observed)