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Administrative data

Description of key information

There is reliable information available from skin irritation and eye irritation studies. Data give indication that the substance is corrosive to skin.

Strong reactions to eyes causes eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Principles of method if other than guideline:
Method: U.S. Consumer Product Safety Commission, Code of Federal Regulations,  Title 16, Section 1500.41; Evaluation with Draize scores.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl

Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest)
Type of coverage:
occlusive
Preparation of test site:
other: shaved, intact and scarified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Amound applied: 0.5 ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
Postexposure period: 14 days
Number of animals:
6
Details on study design:
ADMINISTRATION: 
- Volume administered or concentration: 0.5 ml
- Post dose observation period: 48 hours
- Application to both intact and scarified skin

EXAMINATIONS: 24 and 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Remarks:
necrosis, strong incrustion
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72 h
Score:
1.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
3.6
Max. score:
8
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 2.25
- Edema: 1.33
24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions
Other effects:
no

no further remarks

Conclusions:
Under the present conditions of this study necrosis, strong incrustions and slight to moderate oedema were observed after application of 0.5 ml itest tem (24 hrs exposure) to both intact and sacrified skin of rabbits. Therfore, test item is strong irritating to skin.
Executive summary:

The acute skin irritation properties of the test item were estimated in a modified Draize test. A dose of 0.5 ml test item per animal was applied to both intact and sacrified skin of 6 rabbits under occlusive conditions. After a 24 -hours exposure period the patch was removed and skin irritation was assessed using Draize scale. The average scores at 24 and 72 hours after patch removal are as follows:

- Erythema: 2.25

- Edema: 1.33

24 hours after application all rabbits showed necrosis and slight to moderate oedem, 72 hours after application all rabbits showed strong incrustions.

Therfore, test item is strong  irritating to skin.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods
Principles of method if other than guideline:
Method: other: Draize Test according to Consumer Product Safety Commission (U.S.), Code of Federal Regulations, Title 16, Section 1500.42; 
Evaluation with Draize scores
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl

Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest)
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed
no removal of test substance
Observation period (in vivo):
Ophthalmoscopic examination after 24, 48, 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
Scoring system: Draize (1959)
Irritation parameter:
other: Very strong reactions after 24h observation so that all animals were killed
Remarks:
Based on very strong reactions a score could not determined.
Time point:
24 h
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
probability of severe irritation

no further remarks

Conclusions:
Under conditions of the study test item showed necrosis effects to rabbit eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.
Executive summary:

The acute eye irritation properties of the test item were estimated in a Draize test. An amount of 0.1 ml of the undiluted test substance was instilled into one eye of each of six albino rabbits, and the untreated eye served as control. The eyes are not washed following instillation of test material.

24 hours after application all animals showed necrosis effects on the eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test data on skin irritation alone do not allow to conclude a subcategory concerning corrosive effects. The corresponding Diamine (Isophorone diamine (IPD) (2855-13-2) is classified with category 1C corrosive. As a weight of evidence approach (WoE)it can be concluded that IPAA induces worst case effects similar to IPD. Therefore, IPAA is classified with category 1C of hazard class skin corrosion/irritation.

The test data concerning evaluation of eye damage/irritation show that a classification with category 1 is necessary.