Registration Dossier

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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study reasonably well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.4
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tradename Lial 111 C6-12 alcohols Type A

- Physical state:

- Storage condition of test material:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg
- Housing: stainless steel cages
- Diet: pelleted complete diet
- Water: tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (+/-2)
- Humidity (%): 55 (+/-15)
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12

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): 0.5ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
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: 6x6cm


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

SCORING SYSTEM:Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.83
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.5
Max. score:
1.7
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: Individual 24+48+72 hour scores 3 animals scored 2 the  remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.83.
- Oedema: Individual 24+48+72 hour scores 3 animals scored 1.3 the  remaining 3 scored 1.7. Group mean 24+48+72 hour score 1.5.
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, LIAL 111 (C11) was not a skin irritant according to EU criteria (group mean 24+48+48 hour scores <2). With erythema scores all >=1.5 LIAL 111 is classifiable as a mild (slight) skin irritant according to the GHS.

Classification: not irritating