Citraconic anhydride

Endpoint summary

Description of key information

The substance tested full strength by application of 0.01ml of undiluted sample to an area upon the clipped belly of an albino rabbit caused severe injury like that caused by morpholine (no further data).
The substance is corrosive to the eye according to the Draize scoring method: Corneal involvement, irritation or eye damage that persists for more than 21 days after treatment.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Limited publication

Principles of method if other than guideline:

no information

Species:

rabbit

Interpretation of results:

Category 1 (corrosive)

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

Citraconic acid anhydride tested full strength by application of 0.01ml of undiluted sample to an area upon the clipped belly of an albino rabbit caused severe injury like that caused by morpholine (no further data).

Executive summary:

Citraconic acid anhydride tested full strength by application of 0.01ml of undiluted sample to an area upon the clipped belly of an albino rabbit caused severe injury like that caused by morpholine (no further data).

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

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:

other: The study was performed according to methods similar to OECD 405, not accoring to GLP. Details on test substance and results are limited.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Japanese white rabbits

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Takeo breeder NII-Electronic Library Service
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing:housed in metal cages (39 X 40 X 44 cm)
- Diet (e.g. ad libitum): fed the RC4 diet (Oriental Yeast Co., Tokyo, Japan), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):25 ± 1°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye was served as a blank.

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single application

Observation period (in vivo):

The eyes were examined and the grade of ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment of chemicals.

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE: none

SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score

TOOL USED TO ASSESS SCORE: no data

Irritation parameter:

other:

Basis:

other: all animals

Time point:

other: up to 21 days

Reversibility:

not reversible

Remarks on result:

other: Score III: Corrosive

Irritant / corrosive response data:

The only data given is that the outcome of the test is corrosive for this test substance. This is confirmed by a QSAR.

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The test substance is corrosive to the eye according to the Draize scoring method: Corneal involvement, irritation or eye damage that persists for more than 21 days after treatment.

Executive summary:

The test substance is corrosive to the eye according to the Draize scoring method: Corneal involvement, irritation or eye damage that persists for more than 21 days after treatment.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
No valid data available. K4: Limited publication

Justification for selection of eye irritation endpoint:
K2: The study was performed according to methods similar to OECD 405, not accoring to GLP. Details on test substance and results are limited.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data the substance is classified cat.1 (irreversible effects on the eye) for the eye and Cat. 1B (corrosive) for skin.