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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:
January 15, 2001 - June 18, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
the amount of the aqueous solution applied was 0.5 g instead of 0.5 mL
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
the amount of the aqueous solution applied was 0.5 g instead of 0.5 mL
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
Name of the test material (as cited in the report): Miranol H2M CONC

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A. (Como) and bred by P.O.A.D.A.,  Mandello Lario (Como), Italy.
- Age at study initiation: 9 to 11 weeks at ordering; 10-12 weeks at study initiation
- Weight at study initiation: approximately 2 kg at ordering; 2.3-2.7 kg at study initiation
- Housing: stainless steel cages (63x48x41 cm) equipped with grid floors. Cages were suspended over trays and each tray held an absorbent materiel inspected and changed as necessary.
- Diet (e.g. ad libitum): ad libitum (pelleted diet from Altromin MSK, Altromin, D-32770 Lage,  Postfach 1120, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21 °C
- Humidity (%): 40-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: the day before dosing the dorsal surfaces of the trunk of each animal, on both sides of the midline, were clipped free of hair using an electric clipper equipped with a suitable blade
Vehicle:
unchanged (no vehicle)
Controls:
other: comparison with adjacent untreated skin
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration (if solution): the test material was applied as such (aqueous solution)
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm (6.25 cm^2)
- Type of wrap if used: gauze + aluminium

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated sites were cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature
- Time after start of exposure: 4 hours

SCORING SYSTEM: according OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: solid content of the test material: 50%
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: solid content of the test material: 50%
Irritant / corrosive response data:
See section "Any other information on results incl. tables"

Any other information on results incl. tables

 Scores for erythema reactions  
ERYTHEMA 1h 24h 48h 72h Individual mean scores
 (24, 48 and 72h)
Rabbit 1 1 1 1 0 0.7
Rabbit 2 1 1 1 0 0.7
Rabbit 3 1 1 0 0 0.3

 Scores for oedema reactions  
OEDEMA 1h 24h 48h 72h Individual mean scores
 (24, 48 and 72h)
Rabbit 1 1 1 0 0 0.3
Rabbit 2 1 1 0 0 0.3
Rabbit 3 1 1 0 0 0.3

Other information:

- The animals had a normal weight gain during the 4 days(0.1 kg)

- No indication of a systemic effect

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. On the basis of the obtained results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation.
Executive summary:

The skin irritation potential of a related member of amphoacetates C12 has been investigated according to OECD 404 and GLP. The test material (aqueous solution at approx. 50% solids) was tested for acute dermal irritation in 3 female New Zealand White rabbits, according to OECD 404/EC method B.4, and in compliance with Good Laboratory Practice. The test material, was applied as such on a gauze, in a single dermal dose of 0.5 g, to a 2.5 x 2.5 cm clipped area of the skin, during 4 hours under a semi-occlusive dressing. The cutaneous examinations were performed at 1, 24, 48 and 72 hours after removal of the dressing. The application of the preparation produced very slight erythema (score 1) in all animals at 24 hours but only in two animals at 48 hours after patch removal. The reversibility was complete at 72 hours in all animals. Very slight edema was observed in all animals but only at 24 hours. No other reactions were observed after. The mean individual scores calculated over the 24-72 hour period for each animal were (0.7-0.7-0.3) for erythema, and (0.3-0.3-0.3) for edema. On the basis of these results, the test material (solid content 50%) is not classified as a skin irritant according to the criteria of the CLP Regulation.