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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hous; 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
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.
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

Any other information on results incl. tables

no further remarks

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.