Isobutyl 4-chloro-3,5-diaminobenzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1970-09-24 - 1971-07-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

study sufficiently documented and conducted with other studies indicating that the study was well-performed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Usual methods used at the laboratory, as described in the report

Deviations:

not specified

Principles of method if other than guideline:

- Principle of test: The test item was instilled into the conjunctival sac of the rabbit eye in vivo
- Parameters analysed / observed: irritation / general effects

GLP compliance:

no

Remarks:

study conducted prior to GLP implementation

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl 4-chloro-3,5-diaminobenzoate

EC Number:

251-311-5

EC Name:

Isobutyl 4-chloro-3,5-diaminobenzoate

Cas Number:

32961-44-7

Molecular formula:

C11H15ClN2O2

IUPAC Name:

2-methylpropyl 3,5-diamino-4-chlorobenzoate

Test animals / tissue source

Species:

rabbit

Strain:

other: non-pedigree

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.5 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 50 mg

Number of animals or in vitro replicates:

2

Details on study design:

no further data available

Results and discussion

In vivo

Results

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no changes in conjunctivae, sclerae or corneae were observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating to the eye

Conclusions:

The study was performed in a scientifically reasonable method with sufficient documentation indicating that the study was well-performed. Hence, there is no doubt that the obtained results are reliable. No signs of irritation were observed after instillation of the test item into the conjunctival sac. In the strict sense of Regulation 1272/2008, this result does not enable a classification as irritating as set out in table 3.3.2. However, paragraph 3.2.2.4 states: Generally, primary emphasis shall be placed upon expert judgement, considering human experience with the substance, followed by the outcome of skin irritation testing and of well-validated alternative methods. In consequence, it is justified not to classify the test item as irritant on the basis of the available irritation data.

Executive summary:

50 mg of the test item were instilled into the conjunctival sac of the rabbit eye in vivo (2 rabbits). No changes in conjunctivae, sclerae or corneae were observed, the substance is considered as non-irritating to the eye.