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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Principles of method if other than guideline:
BASF test: Two animals were treated for 1, 5 or 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Propylendiamin
- Analytical purity: 99 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.0 and 3.1 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal served as control
Amount / concentration applied:
pure
Duration of treatment / exposure:
1, 5 and 15 min
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Necrosis-score
Basis:
mean
Remarks:
1, 5 and 15 min exposure
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: Necrosis-score
Basis:
mean
Remarks:
1, 5 and 15 min exposure
Time point:
other: 8 d
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
Slight erythema (grade 2), slight edema (grade 1), partly extended beyond the area of exposure were observed in all animals on the day of application. After a 1 min exposure necrosis (grade 3) was observed. A 5 min or 15 min exposure led to leathery-like full thickness necrosis (grade 3).

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
The test substance caused severe necrosis after an 1-min exposure. The first scoring was made 24 h after the application of the test substance. As it cannot be excluded that the corrosive effects already occurred during an observation period ≤ 1 h, the test substance is assigned to category 1A .
Executive summary:

In a primary skin irritation study (BASF test), the undiluted test substance was applied to the back of two Vienna White rabbits for 1, 5 or 15 min using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily.

After a 1-min exposure necrosis (grade 3) was observed. A 5-min or 15-min exposure led to leathery-like full thickness necrosis (grade 3). Additionally, slight erythema (grade 2) and slight edema (grade 1), partly extending beyond the area of exposure were observed in all animals on the day of application.