Diaminotoluene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 1982 to March 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: standardised study without detailed documentation. Compliance with GLP was not mentioned. Purity of the test substance unknown.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Diaminotoluene

EC Number:

246-910-3

EC Name:

Diaminotoluene

Cas Number:

25376-45-8

Molecular formula:

C7H10N2

IUPAC Name:

3-methylbenzene-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): m-toluylendiamin
no other data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill, Ltd. Huntingdon, England
- Age at study initiation: no data
- Weight at study initiation: 3,3-4,9 kg
- Housing: individually in cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): ca. 60
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye was used as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

continuous (no wash)

Observation period (in vivo):

7 days. The eyes were examined at 1, 24, 48, 72 hours, and day 7 after test substance application.

Number of animals or in vitro replicates:

3 (1 male and 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE No data

SCORING SYSTEM: similar to the commission Directive 2004/73/EC


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and day 7

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and day 7

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and day 7

Score:

0 - 0.33

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and day 7

Score:

0

Max. score:

4

Irritant / corrosive response data:

See table 1 in field "remarks on results including tables and figures".

Other effects:

None

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility	Cornea Max. score: 4	Iris Max. score: 2	ConjunctivaeMax. score: 3	ChemosisMax. score: 4
60 min	-/0/-	-/0/-	-/0/-	-/1/-
24h	0/0/0	0/0/0	0/1/0	0/0/0
48 h	0/0/0	0/0/0	0/1/0	0/0/0
72 h	0/0/0	0/0/0	0/1/0	0/0/0
average 24h, 48h, 72h	0/0/0	0/0/0	0/0.33/0	0/0/0
Reversibility*)	-	-	c. (at day 7)	-
Average time (day) for reversion	-	-	-	-

*) Reversibility: c. = completely reversibility; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU and EU-GHS

Conclusions:

Under the conditions of this test, m-Toluylendiamin is not irritating according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.

Executive summary:

In a primary eye irritation study (Starke B, 1982), 100 mg of m-Toluylendiamine (purity unknown) was intilled into the conjunctival sac of adult New Zealand White rabbits (1 male and 2 females). Animals were observed for 7 days. The eye irritation was assessed at 1, 24, 48, 72 hours and day 7 after administration. The mean score was calculated across 3 scoring time, 24, 48, 72 hours after instillation, for each animal separately.

The test item did not elicit any severe eye irritation at any of the observation time. Indeed, the individual mean scores for cornea, iris,

and chemosis were 0 and for conjunctivae 0.33. Redness had completely desappeared at day 7. Under the conditions of this test, m-Toluylendiamin is not an eye irritant according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.