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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:
supporting study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Although the formulation only contained 10% active ingredient, it is considered relevant, however less adequate for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
EEC directive 84/449 EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
- Age at study initiation: Not provided
- Weight at study initiation: 2.4-2.8 kg
- Fasting period before study: Not applicable
- Housing: Individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Ad libitum, Ssniff MÜ Z® (Alleindiät für Zuchtkaninchen),manufactured by Ssniff spezialdiäten GmbH, 4770 Soest/ Westfalen, pellets, 1.01.5 cm long, 0.5 cm diameter
- Water (e.g. ad libitum): Ad libitum, drinking bottles, drinking water as for human consumption, analytical and bacteriological controls every six months
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C (measured with thermohygrometer twice daily)
- Humidity (%): 50-85 % (measured with thermohygrometer twice daily)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12 (artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: aqua deion.
Controls:
other: an adjacent area of untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 10 % v/v


Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: semi-occlusive dressing consisting of Kosmoplast® (Medilog), which was held in place by non-irritating tape (Elastoplast®, beiersdorf AG, Hamburg) , and Stülpa® (P. Hartmann AG, Heidenheim/Brenz), which enveloped the whole of the animal’s trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or an appropriate solvent
- Time after start of exposure: 4 h

SCORING SYSTEM:
Draize sheme as stipulated by OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 30-60min, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60min, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60min, 24h, 48h, 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance in a 10% v/v aqueous solution is not irritating.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not irritant under the conditions of this experiment.
Executive summary:

The potential toxicity of the test item was assessed in an acute dermal irritation/corrosion test on 6 albino rabbits. The skin was exposed to the test substance for 4 h. Animals were examined for signs of erythema and edema at 30-60 min, 24, 48 and 72 h after the end of the exposure period, showing absence of any signs up to 72 h.