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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:
1996-03-11 to 1996-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white, HsdPoc:NZW
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Sex: female
- Weight at study initiation: 3.3; 3.6; 4.2 kg
- Housing: single
- Diet (e.g. ad libitum): Sniff K 4, complete feed for rabbits, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Total volume applied: 0.5 ml undiluted test item
Duration of treatment / exposure:
4 hour(s)
Observation period:
30-60 minutes, 24, 48, and 72 hours after  patch removal
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml test item
- Occlusion: gauze dressing fixed with non-irritant plaster, Acrylastic  bandage
- Removal of test substance: washing with warm water
- Post exposure period: 3 days
EXAMINATIONS
- Examination time points: 30-60 minutes, 24, 48, and 72 hours after  patch removal
- Scoring system: OECD Guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable

Any other information on results incl. tables

no other results

Applicant's summary and conclusion

Conclusions:
According to the study, the test item showed no irritant effect on the skin of female rabbits.
Executive summary:

The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .

To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

According to the study, the test item showed no irritant effect on the skin of female rabbits.