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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

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

Test animals

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: males 9, 10 months; female 10 months
- Weight at study initiation: males 2.59, 2.67 kg, female 2.69 kg
- Housing: individually
- Diet: approx. 120 g/day x animal, standard diet sniff K, special diet for rabbits
- Water: ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-20.5°C
- Humidity (%): 53-68%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20.07.1993 To: 30.07.1993

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: control site at the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.21 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: cellulose fabric coated with natural rubber, synthetic film glue

REMOVAL OF TEST SUBSTANCE
- Washing: remaining test material was gently washed off as far as possible
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
An edema was not observed in all three animals during the observation period.
Other effects:
Systemic toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected.

Any other information on results incl. tables

The single application (4 hours, occlusive patch) of 0.5 g L-threonine feed grade to the intact skin of each of three rabbits caused very slight changes in two animals.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information