Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according OECD guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623
- Weight: 2.3-2.5 kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h, 7d, 14d, 21d
Number of animals:
3
Details on study design:
TEST SITE
- Clipped area: 10*10cm
- Area of exposure: 2.5cm*2.5cm
- % coverage: 100
- Type of wrap if used: 16-layer gaze fixed with 2.5cm adhesive Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was cleaned with mild soap and lukewarm water
- Time after start of exposure: 4h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Erythema and Eschar Formation
Basis:
mean
Remarks:
three animals
Time point:
other: mean of 24h, 48h and 72h reading
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: after 21 days rests of scales were observed in all animals
Irritation parameter:
edema score
Remarks:
Oedema Foramtion
Basis:
mean
Remarks:
three animals
Time point:
other: mean of 24h, 48h and 72h reading
Score:
2.8
Max. score:
4
Reversibility:
fully reversible within: after 21 days rests of scales were observed in all animals
Irritant / corrosive response data:
no evidence for corrosion reported

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS EC 1272/2008
Conclusions:
irritating to skin
Executive summary:

The acute skin irritant effect of SAT 970 419 was investigated according to the method

recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion", 1992, and

EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.

Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4

hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours

as well as 7, 14 and 21 days after termination of exposure.

Moderate to severe skin reactions were observed.

Under the experimental conditions described in this report, the mean score for erythema was 2.7 (2.00, 3.00, 3.00)

and for oedema 2.8 (2.00, 3.33, 3,00). After 21 days rests of scales on both sides were observed in all animals.

Based on this result the substance has to be labeled as irritating to skin according to EU GHS EC 1272/2008.