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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Alcohols, C12-16
EC Number:
272-490-6
EC Name:
Alcohols, C12-16
Cas Number:
68855-56-1
IUPAC Name:
tetradecan-1-ol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days ( Examination time points: 1, 24, 48 and 72 hours, 5 and 7 days.)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6x6 cm


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

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 hours
Score:
1.2
Max. score:
1.7
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: Individual mean 24+48+72 hour scores 4 rabbits scored 1, 2  rabbits scored 1.7 (Group mean 24+48+72 hour score 1.2)
- Oedema: All rabbits scored 1 at 24, 48 and 72 hours. The group mean and  individual scores are therefore 1.

REVERSIBILITY: 
Erythema and oedema persisted throughout the 7 day  observation period in all animals (grade 1). Group mean scores at 5 and 7  days were 1 for both erythema and oedema.
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following a 4 hour occluded exposure to rabbit skin Alchem 125 considered as non-irritant by EU criteria and a mild irritant by GHS (class 3).