3-aminomethyl-3,5,5-trimethylcyclohexylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-11-24 - 1983-11-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

EC Number:

220-666-8

EC Name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

Cas Number:

2855-13-2

Molecular formula:

C10H22N2

IUPAC Name:

3-aminomethyl-3,5,5-trimethylcyclohexylamine

Details on test material:

Isophorone diamine, purity: 99.70 %
0.14 % isophorone aminonitril
0.12 % N-methyl isophorone diamine

Test animals / tissue source

Species:

rabbit

Strain:

other: Small white Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: female
- Source: Dr. Karl Thomae, Biberach
- Weight at study initiation: 2.3 kg
- Sex: female
- Weight at study initiation: 2.8 kg
- Controls: untreated eye
- Housing: single housing in stainless steel cages
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Controls: right eye

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

Postexposure period: 24 hours
Evalutation took place after 1 h and 24 hrs

Number of animals or in vitro replicates:

1

Details on study design:

Teh test item was applied to the sac, formed by retracting the lower eyelid of the left eye. The right eye remained untreated and served as control. The test product was not washed out.
An evaluation of the reaction according to Draize was planned, but due to the strong corrosive effects of the test substance a scoring was not possible and therefore not reported.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 24 hours

Score:

110

Max. score:

110

Reversibility:

not reversible

Remarks on result:

other: Due to the strong corrosive effects of the test substance Isophorone diamine a scoring was not possible and therefore not reported (details see in section "Remarks on results including tables and figures")

Irritant / corrosive response data:

The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment
conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.

Other effects:

no other effects

Any other information on results incl. tables

Due to the strong corrosive effects of the test substance Isophorone diamine a scoring was not possible and therefore not reported. The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.

Applicant's summary and conclusion

Conclusions:

The test item showed a strongly irritant and corrosive effect on the eye and on the mucosa of the rabbit under the conditions of the study.

Executive summary:

The test item was investigated for irritant effects on the eye and associated mucous membranes of 1 female rabbit according to OECD TG 405 (1981). The test substance was applied in a single dose of 0.1 ml into the conjuntival sac of the animal. The undiluted substance produced serious injury almost immediately after application (corrosive effects, opalescence). 24 hours after treatment conjunctiva showed necrosis. Due to the corrosive effect of the test material, only 1 animal was used and the experiment terminated after 24 hours.The lesions were not reversible. Therefore, Isophorone diamine is considered to be corrosive.