Alcohols, C9-11

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C9-11

EC Number:

266-367-6

EC Name:

Alcohols, C9-11

Cas Number:

66455-17-2

Molecular formula:

CnH(2n+2)O n= 9..11

IUPAC Name:

Alcohols C7-C9

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/72h

Score:

2.67

Remarks on result:

other: intact skin

Results 2

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.