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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:
17 Dec - 26 Dec 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study but no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Amines, hydrogenated tallow alkyl
EC Number:
262-976-6
EC Name:
Amines, hydrogenated tallow alkyl
Cas Number:
61788-45-2
IUPAC Name:
61788-45-2
Constituent 2
Reference substance name:
Hydrogenated Tallow Alkylamines
IUPAC Name:
Hydrogenated Tallow Alkylamines
Details on test material:
- Name of test material (as cited in study report): Noram SH

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre d´Elevage Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Weight at study initiation: 2.8 kg
- Housing: individual housing; polystyrene cages equipped with a food container and a water bottle
- Diet (e.g. ad libitum): certified pelleted diet, ref. 112C (U.A.R., 91360 Villemoisson sur Orge, France); ad libitum; analysis of the diet for quality and major contaminants was performed
- Water (e.g. ad libitum): drinking water filtered by a 0.22 micron filter membrane; ad libitum; bacteriological and chemical analyses of the water and detection of contaminants were made periodically

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
1 h or 4 h
Observation period:
1, 24, 48, 72 h and 4, 5, 6, 7, 8, 9 days
Number of animals:
6 (3 animals for the 1 h exposure and 3 animals for the 4 h exposure)
Details on study design:
TEST SITE
- Area of exposure: The test material were placed on a 6 square centimetre dry gauze pad, which was then applied to the right flank.
- Type of wrap if used: The test material and the gauze pad were held in contact with the skin by means of a semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment site was washed with sterile distilled water.
- Time after start of exposure: 1 or 4 h

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
other: no findings
Remarks on result:
other: exposure 1 hour
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
1.77
Max. score:
3
Reversibility:
fully reversible within: 7 - 9 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 day
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
other: exposure 4 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24H / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
other: no findings
Remarks on result:
other: exposure 1 hour
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
1.55
Max. score:
3
Reversibility:
fully reversible within: 5 - 8 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
other: no findings
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: exposure 4 hours
Irritant / corrosive response data:
After the 1 h exposure, no erythema or edema were noted during the observation period in any of the 3 test animals.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, the test material Noram SH has to be considered as irritating to skin.
Executive summary:

In an OECD TG 404 study, the test material Noram SH (hydrogenated tallow alkyl amine), a yellow-beige solid (purity not given), was semi-occlusively applied for 1 and for 4 hours to the shaved skin of six New Zealand White rabbits (3 animals per exposure period). The test substance was moistened with water to ensure good skin contact and test substance remaining after patch removal was removed with water. Average scores for erythema were 2.0 (24 hours), 1.7 (48 hours) and 1.7 (72 hours). Scores for oedema were 2.3, 1.7 and 1.3 for the same time points. Erythema cleared by day 9 and oedema by day 8 after removal of the patches. Based on the findings of this study, the test material has to be considered as irritating to skin.