3-chloro-p-toluidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-chloro-p-toluidine

EC Number:

202-446-3

EC Name:

3-chloro-p-toluidine

Cas Number:

95-74-9

Molecular formula:

C7H8ClN

IUPAC Name:

3-chloro-4-methylaniline

Details on test material:

IUCLID4 Test substance: other TS: 3-chloro-p-toluidine; purity: at least 99 %; impurities: max. 1 % p-toluidine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each rabbit served as control

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, 72 hours, 7 days after application of test substance the eyes were examined

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

reddening of conjunctiva

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.4

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Remarks:

swelling of conjunctivae

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

One hour after application of test substance clearly defined swelling of the conjunctiva was observed. Some bloodvessels showed a defined hyperemia. The iris was reddened in two animals. On the cornea diffuse opacity regions were seen. These findings came along with white-brownish defluxion.
24 up to 72 Hours after application of test substance slight to clear swelling of conjunctiva was observed. The conjunctiva showed a considerable hyperemia up to diffuse strong reddening. The iris of all animals was reddened. On the cornea diffuse opacoty regions were seen. In two animals bleeding in the conjunctiva were observed. These findings came along with a white defluxion.
7 days after application of the test substance the appearance of irritation was reversible.

Any other information on results incl. tables

Results:

Time post application	1 hour			24 hours			48 hours			72 hours			7 days
Animal Number	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Swelling of conjunctiva	2	2	2	2	2	1	1	1	1	1	1	1	0	0	0
Reddening of conjunctiva	1	1	1	2	1	2	3	3	3	3	2	3	0	0	0
Iris	0	1	1	1	1	1	1	1	1	1	1	1	0	0	0
Corneal turbidity	1	1	1	1	1	1	1	1	1	1	1	1	0	0	0
Fluorescein-Test				2	3	2				3	1	4	0	0	0
Eye defluxion
-white-brownish	x	x	x
-white				x	x	x	x		x	x		x
Bloody Conjunctiva		x	x	x	x	x	x	x	x	x	x	x
Reddened Iris		x	x	x	x	x	x	x	x	x	x	x

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Executive summary:

In an eye irritation study according to OECD TG 405 the test substance was tested in the eyes of 3 New Zealand White rabbits.

24 hours before application of test substance, the eyes of the test rabbits were examined to detect posible damages on the cornea. Only animals showing no findings were used. 100 mg test substance was applied in a single dose into the conjunctival sac of the left eye of the test animals, the other eye served as control. 1, 24, 48, 72 hours and 7 days after application of test substance the eyes were examined.

One hour after application of test substance clearly defined swelling of the conjunctiva was observed. Some bloodvessels showed a defined hyperemia. The iris was reddened in two animals. On the cornea diffuse opacity regions were seen. These findings came along with white-brownish defluxion.

24 up to 72 Hours after application of test substance slight to clear swelling of conjunctiva was observed. The conjunctiva showed a considerable hyperemia up to diffuse strong reddening. The iris of all animals was reddened. On the cornea diffuse opacoty regions were seen. In two animals bleeding in the conjunctiva were observed. These findings came along with a white defluxion.

7 days after application of the test substance the appearance of irritation was reversible.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Irrit. 2 ( H319: Causes serious eye irritation.) is justified.