4-chloro-2-nitroaniline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.41

GLP compliance:

no

Remarks:

pre-guideline study

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-2-nitroaniline

EC Number:

201-925-4

Cas Number:

89-63-4

Molecular formula:

C6H5ClN2O2

IUPAC Name:

4-chloro-2-nitroaniline

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Hoe: HIMK (SPFWiga)
- Source: Hoechst, breeding colony
- Weight at study initiation: 1,5 - 2,5 kg
- Housing: single caged
- Diet: ERKA 8300, ad libitum
- Water: ad libitum

Test system

Type of coverage:

other: covered with an impervious rubberized cloth

Preparation of test site:

other: shaved or shaved and abraded with a scarifying instrument

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

0.5 g, mixed with 0.35 ml physiol. saline

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

0.5 g of the test substance, mixed with 0.35 ml pyhsiol. saline, was applied under a square gauze patch, measuring 2,5 x 2,5 cm, on the abraded and intact skin of the albino rabbit, clipped free of hair. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with impervious rubberized cloth. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated. Readings are again made after 48 h and at the end of a total of 72 hours.
(Abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding)

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24 h and 72 h

Score:

0.4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

According to FDA Guideline the test item is not irritating to skin (PDII < 0.5).

According to the classification criteria of Regulation (EC) No 1272/2008 the test material has to be regarded as not irritating to skin under these test conditions. This conclusion is legitimate although the testing regime differs from today's standard methods (e.g., exposure of intact and scarified skin, application period 24 hours instead of 4 hours, deviating reading times, scoring system is identical to the currently used system).

Executive summary:

Test material was subject to an acute dermal irritation/corrosion test in 6 Himalaya rabbits according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were watched for up to 48 hours after end of exposure. No skin reactions were observed.

Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.