Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP guideline study, dermal application under occlusive conditions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DRIVERON (MTB)
- Physical state: clear liquid
- Analytical purity: 99.9%

Test animals

Species:
rabbit
Strain:
other: Kleine weisse Russen, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0-2.4 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 6, 8, 10 and 14 days after treatment
Number of animals:
3 males and 3 females
Details on study design:
Rabbits subjected to MTBE under occlusive patch for 4 hours. After the exposure, the residual substance was washed out with water and the skin reaction was estimated and scored after 1, 24, 48 and 72 hours and 6, 8, 10 and 14 days according to OECD guidelines.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary irritation score
Basis:
mean
Time point:
other: 1-72 hours
Score:
5
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Moderate to severe edema and moderate erythema one hour after the end of exposure was observed. The effects lasted the first 8 days of the 14 days of observation.

Applicant's summary and conclusion