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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:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to current guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C9-11 alcohols Cas# 66455-17-2 (Neodol 91) 84% linear monobranched at the 2 position

- Physical state: a clear liquid

- Storage condition of test material: ambient conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Camm Research Institute, New Jersey, USA
- Age at study initiation:
- Weight at study initiation: 2.2 - 3 kg
- Housing: individual, suspended, stainless steel cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, abraded and intact skin
Vehicle:
other: undiluted
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 and 48 hours after exposure and at 7 days.
Number of animals:
3M, 3F
Details on study design:
TEST SITE
- Type of wrap if used: gauze patches were held in place with strips of Blenderm tape. The entire trunk was then covered in plastic covering, which was secured and sealed and then wrapped with elastic bandage to immobilize and occlude the patches.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was wiped away with a moist towel.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72h
Score:
2.67
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72h
Score:
1.46
Remarks on result:
other: intact skin
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: Mean 24 + 72 hour score for 6 animals intact skin 2.67,  abraded skin 2.75.
- Oedema: Mean 24 + 72 hour score for 6 animals intact skin 1.46, abraded  skin 1.54.
-PDII 4.2

REVERSIBILITY: At 7 days all the application sites had developed eschar  (scored as 4) so the effects had increased over the period of the study.  
PII 4.2.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Neodol 91 was a skin irritant following 24 hour occlusive application to rabbit skin according to both EU and GHS classification systems.