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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines, for read-across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
-reliability scoring based on 2002 guideline
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 4 to 9 months old
- Weight at study initiation: 4440 to 4940 g (males) and 4100 to 4982 g (females)
- Housing: Housed individually
- Diet (e.g. ad libitum): Food (standard rabbit diet, S.Q.C., Special Diet Services Ltd., Essex), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply (whether or not water was administered ad libitum was not reported).
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: dorsal hair between the shoulders and hindquarters was closely shorn
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals/sex
Details on study design:
TEST SITE
- Area of exposure: dorsal hair between the shoulders and hindquarters
- % coverage: 2 cm x 2 cm
- Type of wrap if used: The patch and surrounding skin was covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated skin was not washed.
- Time after start of exposure: After 4 hours, the wrapping and patch were removed.

SCORING SYSTEM: The test site was examined and scored for erythema and oedema on a graded scale of 0 to 4 using the criteria given below. Observations were made at 30 minutes after the removal of the patch (i.e. approximately 4 hours after application) and at 24, 48, and 72 hours, and 7 days after application. The mean score of each rabbit at each observation time and the group mean 24, 48, and 72 hours were calculated.

Erythema scale:
No erythema 0
Very slight erythema (perceptible, area not defined) 1
Well defined erythema (pale red, area well defined) 2
Moderate to severe erythema (bright red, area well defined) 3
Severe erythema (beet or crimson red) 4

Oedema scale:
No oedema 0
Very slight oedema (perceptible, edges of area not defined) 1
Slight oedema (edges of area defined by raising) 2
Moderate oedema (area well defined, raised I mm) 3
Severe oedema (area raised more than 1 mm, extends beyond exposure area) 4

Injury in depth:
Escharosis, necrosis 8
A score of 8 is equivalent to scoring 4 for erythema and 4 for oedema.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h, 24h, 48h, 72 h, and 7 days
Score:
0
Max. score:
4
Remarks on result:
other: All individual scores were 0 at all time-points indicated.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h, 24h, 48h, 72 h, and 7 days
Score:
0
Max. score:
4
Remarks on result:
other: All individual scores were 0 at all time-points indicated.
Irritant / corrosive response data:
There were no skin reactions following the application of undiluted secondary butyl alcohol to rabbit skin for 4 hours. The test material is therefore not a skin irritant in rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met