3-aminomethyl-3,5,5-trimethylcyclohexylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Summer of 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", by the staff of the Division of Pharmacology, FDA; scoring according to Draize (1959)

Principles of method if other than guideline:

Based on "Appraisal of the safety of chemicals in foods, drugs and cosmetics", FDA / Draize (1959)

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:

IPD = isophorone diamine of Veba-Chemie AG, purity not reported

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Age: adult
- Weight at study initiation: mean 2.5 kg
- Diet: ad libitum, Rabbit standard diet (Höing 222)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

unchanged (no vehicle)

Controls:

other: 2 untreated skin areas per animal (both depilated, one scarified)

Amount / concentration applied:

Total volume applied: 2 x 0.5 ml / animal (undiluted)
- Occlusion:
Each 0.5 ml test substance on two plasters,
fixed to separate areas of the skin (both depilated, one scarified),
trunk wrapped in rubber sheet for 24 hours

Duration of treatment / exposure:

24 hour(s)
Removal of test substance: no

Observation period:

Postexposure period: 48 hours

Number of animals:

6

Details on study design:

- Examination time points: 24 hours = patch removal and 72 hours
- Scoring system: Draize scores, mean of two readings

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hous; 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours; 72 hours

Score:

> 0

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The skin had become hard and leatherlike. Scoring was not possible.

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours; 72 hours

Score:

> 4

Max. score:

8

Reversibility:

not reversible

Remarks on result:

other: The skin had become hard and leatherlike. Edema scoring was not possible.

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 4.0
- Edema: The skin had become hard and leatherlike. Scoring was not possible.
REVERSIBILITY: Similar severity of effects was observed at both readings, i.e. there was no indication of reversibility within the observation period.

Other effects:

no other effects

Applicant's summary and conclusion

Conclusions:

Isophorone diamine has to be considered to be corrosive to the skin of rabbits und the conditions and according to the results of the study.

Executive summary:

In this study with 6 adult rabbits 0.5 ml undiluted 3-aminomethyl-3,5,5-trimethylcyclohexylamine (Isophorone diamine) was applied to the shorn dorsal skin of the animals ( intact and scarified) and covered with gauze and adhesive tape for 24 hours. The results were assessed at patch removal (24h) and 48 hr later (72 h), the skin had become hard and leatherlike. Edema scoring was not possible. Similar severity of effects was observed at both readings, i.e. there was no indication of reversibility within the observation period. In the study Isophorone diamine is described to be a severe irritant according to the scoring system used. Thus, under the conditions and according to the results of this study isophorone diamine has to be considered to be corrosive to the skin of rabbits.