Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TAME.
- Physical state: clear colorless liquid
- Analytical purity: 98.4 %
- Lot/batch No.: 25-30.11.89
- Storage condition of test material: room temperature, in darkness

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK
- Age at study initiation: not indicated
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: appr. 100-120 gram per animal/day
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/ artificial illumination from 6 to 18 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral skin of each rabbit area acted as control.
Amount / concentration applied:
500 µl TAME
Duration of treatment / exposure:
4 hours
Observation period:
Draize scores were recorded for each animal at 1, 24, 48 and 72 hours and 7 days after the application of the substance.
Number of animals:
3
Details on study design:
A semiocclusive patch was used to cover a clipped patch on the dorso-lateral area of the trunk to which 500 μl of the test substance had been applied. The patch was left in place for 4 hours after which the exposed skin area was washed carefully. The contralateral skin area acted as control. Dermal irritation was scored and the degree of erythema and oedema, together with any other lesions, was recorded. Draize scores were recorded for each animal at 24, 48 and 72 hours after the application of the substance. The index was separately calculated for erythema/eschar and oedema formation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours and 7 days
Score:
0
Max. score:
4
Reversibility:
other: no effects were seen at all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours and 7 days
Score:
0
Max. score:
4
Reversibility:
other: no effects were seen at all
Irritant / corrosive response data:
All scores were zero at all time points. TAME was not irritating to albino rat skin.

Applicant's summary and conclusion