Registration Dossier

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:
1984-01-24 to1984-02-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: white russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-6 months
- Weight at study initiation: 1.8-2.5 kg
- Housing: singly in stainless steel cages model: Asta
- Diet (e.g. ad libitum): ad libitum, standard chow: ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 1°C
- Humidity (%): 50-60 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
other: left side intact, untreated areas
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test item moistened with water


Duration of treatment / exposure:
4 hour exposure
Observation period:
up to 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²/animal
- Type of wrap if used: Areas were covered by linen patches which were fixed with Acylastic, P.Beiersdorf und Co. AG, Hamburg
- Differences to guideline: Abraded and intact skin was treated and observed, but only intact skin was used for evaluation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM:
- Method of calculation: Scoring according to the method of Draize et al., 1944

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: effects on intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: effects on intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: effects on intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: effects on intact skin
Irritation parameter:
erythema score
Basis:
animal: #2,#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: effects on intact skin

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal on intact skin at each observation time up to removal of each animal from the test

Score at time point/ Reversibility

Erythema

Edema

 

Max. score: 4

Max. score: 2

24 h

3/0/0

1/0/0

48 h

2/1/1

1/0/0

72 h

1/1/1

0/0/0

Average 24 h, 48 h, 72 h

2/0.67/0.67

0.67/0/0

Reversibility *)

c.

c.

Average time (unit) for reversion

6 days

6 days

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present conditions, occlusive application of the test item for 4 hours to intact and abraded rabbit skin revealed moderate irritating effects (moderate erythrema and slight edema) only in one out of three animals. The other two animals showed no reaction or exhibited a slightly irritating effect, respectively. However, these effects were fully reversible after maximum 6 days. Therefore the test item is not classified according to GHS citeria.