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Diss Factsheets

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:
July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane
EC Number:
203-600-2
EC Name:
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane
Cas Number:
108-62-3
Molecular formula:
C8H16O4
IUPAC Name:
2,4,6,8-tetramethyl-1,3,5,7-tetraoxocane
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name: P0071
- Physical appearance: Crystalline white solid
- Storage requirements: stored at ro.om temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Santin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, Hull 4QE, UK
- Age at study initiation: young adults
- Weight at study initiation: 3.07-3.5 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex, UK
- Water (e.g. ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 44-53%
- Photoperiod (hrs dark / hrs light): 14h artificial light & 10h darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after treatment
Number of animals:
3 young adult females
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: ghauze patch, secured with impermeable adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No abnormal skin reactions were noted on any treated site during the observation period. A primary irritation index of 0 was obtained. The test item was regarded as non-irritant to rabbit skin. No corrosive effects were noted.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was found to be non-irritating to rabbit skin.
Executive summary:

A study was carried according to OECD test method no. 404 to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. A single 4-hour application of the test substance produced a primary irritation index of 0, the test item was therefore classified as a non-irritant to rabbit skin. No corrosive effects were noted.