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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 October 1999 - 14 MArch 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14 (even numbered), propoxylated, aminated
Molecular formula:
C12H27N (C3H6O)n n=1-5, C14H31N (C3H6O)n n=1-4
IUPAC Name:
Alcohols, C12-14 (even numbered), propoxylated, aminated
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: test material was provided by the sponsor

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare Marland
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.767 - 3.067 kg
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 DEcember 1999 To: 3 January 2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): neat
Duration of treatment / exposure:
The animals were exposed for 3min, 60min and 4h
Observation period:
The exposure sites were scored immediately after the exposure period and daily from day 2 to 15. In addition, the 3min exposure site was also scored approximately after 60min.
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk
- Type of wrap if used: gauze and semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with mineral oil
- Time after start of exposure: substance was removed after 3min, 60min and 4h

OBSERVATION TIME POINTS
3min exposure: 3min, 60min, daily days 2-15
60min exposure: 60min, daily days 2-15
4h exposure: 4h, daily days 2-15

SCORING SYSTEM:
- Method of calculation: the effects were scored according to the Draize method.
The Primary Irritation Index (PII) was calculated according to OECD and OSHA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
OECD
Basis:
mean
Time point:
other: immediate, 24h, 48h and 72h
Score:
6.6
Reversibility:
not reversible
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
OSHA
Basis:
mean
Time point:
other: immediate and 48h
Score:
5.4
Reversibility:
not reversible
Irritant / corrosive response data:
Necrosis was observed in all animals tested with the test item during the duration of the study. After 3min exposure only very slight erythema and no edema was observed immediately after the exposure (2/6 animals) and 60min after exposure (5/6 animals).

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The test item was found to be corrosive. DOT packing group classification II.
Executive summary:

The purpose of the study was to determine the potential of the test item to have irritant/ corrosive effects when in contact with rabbit skin.

The test item was applied to 3 sites of the clipped dorsal trunk of New Zeland White rabbits. The exposure times for the different sites were 3min, 60min and 4h. Observation of dermal irritation and corrosivity was performed for each site immediately after the exposure and daily from day 2- 15. In addition, the 3min exposure site was also scored approximately after 60min. The grading of the irritation was according to the method of Draize.

Necrosis was observed in all animals tested with the test item during the duration of the study. After 3min exposure only very slight erythema and no edema was observed immediately after the exposure (2/6 animals) and 60min after exposure (5/6 animals).

The test item was found to be corrosive.