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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
granulate
Specific details on test material used for the study:
FAT 41001/D

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2000-2260 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±3
- Humidity (%): 30-70
- Air changes (per hr):approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 females
Details on study design:
SCORING SYSTEM:
After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, (cf. Table 1), after 1, 24, 48, 72 hours and during the following observation period.
The score obtained is defined as the "index of primary cutaneous irritation".

INDEX CLASSIFICATION
<0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0.33
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: only 1 animal could be assessed due to strong colouring of the skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The animals showed a normal body weight development.
As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the scoring was performed according the values for edema only.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
Executive summary:

Acute dermal skin irritation/corrosion study in the rabbits was carried out in accordance with OECD guideline 404. The animals showed a normal body weight development.

As in two of three rabbits scoring was not possibile due to intensive blue staining by the test compound, the evaluation was performed with the values for edema only.

It can be concluded that the test substance is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.