4-chloro-2-nitroaniline

Eye irritation

Administrative data

Endpoint:

eye 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: Federal Register Vol 38, no 187, S. 27019, 1973

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 / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues 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

Vehicle:

physiological saline

Controls:

other: the right eyes served as control respectively

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 100 mg, mixed with 3 drops physiol. saline

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

- Washing: Washing with physiological saline 24 h after administration

Scores are assessed by use of a binocular loupe. Scores after 48 and 72 h by applying 0.01 % solution of fluorescein sodium, under UV light
The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 1 h

Score:

5

Max. score:

110

Irritant / corrosive response data:

The maximum mean score of 5 was observed 1 h after application. Immediately after application yellow staining of the slera and cornea (partly) was observed. which was fully reversible after 48 h.
Cornea, iris, conjunctiva redness and chemosis scores are not recorded in the report.

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 (MMTS < 10).

According to the classification criteria of Regulation (EC) No 1272/2008 the test material has to be regarded as not irritating to eyes under these test conditions. This conclusion is legitimate although the testing regime differs only slightly from today's standard methods (scoring system is identical to the currently used system)

Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 6 Himalayan White rabbits according to FDA guideline. 100 mg test substance, mixed with 3 drops of physiol. saline, were placed into the conjunctival sac of one eye of 6 rabbits. The effects were observed for 72 h. The test item caused a maximum mean irritation score of 5 1 h after application. Sclera and cornea (partly) showed yellow staining immediately after application, which was fully reversible after 48 h. Therefore, the test item has to be regarded as not irritating to the eye according to Regulation (EC) No 1272/2008.