Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1984-05-30 - 1984-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted study similar to guideline (limited documentation; 2 hours exposition, occlusive coverage, 5 animals, 48-hours observation period)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation, 2 hours treatment, occlusive coverage, 5 animals, 48-hours observation period
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, 2-hexyldecyl esters
EC Number:
309-832-1
EC Name:
Fatty acids, C16-18, 2-hexyldecyl esters
Cas Number:
101227-09-2
IUPAC Name:
101227-09-2
Details on test material:
- Name of test material (as cited in study report): Isohexadecylstearat
No further details provided

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 4976 g
No additional details provided.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin size of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
2 hours
Observation period:
not specified
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: 3 cm x 30 cm dorsal skin area
- Type of wrap if used: linen patch under an occlusive dressing.

REMOVAL OF TEST SUBSTANCE
Not specified

SCORING SYSTEM:
Not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all treated animals
Time point:
other: 24-48 hours
Score:
ca. 0.2
Max. score:
4
Reversibility:
other: not specified
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all treated animals
Time point:
other: 24-48 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
It is reported that a slight erythema (score assumed to be 1) was observed only in one animal immediately after treatment up to 48 hours thereafter. No further skin reaction was observed in the remaining 4 animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information