Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 29th to Dec 2nd 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, performed in conformity with GLP-principles
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): P5497 (identical with L-Carnitine-L-Tartrate)
- Physical state: white, fine powder
- Purity test date: not indicated
- Lot/batch No.: 13
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervoerde, Neuendamm 88/Germany
- Housing: individual housing
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): Artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
the test substance was moistened with the vehicle
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
Signs of erythema and oedema were recorded at 30-60 min, 24, 48 and 72 h after patch removal .
Number of animals:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No signs of irritation oberved during the study.
Other effects:
There were no signs of toxicity, irritation or ill health observed in any animal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be non-irritant to rabbit skin. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation according to the European CLP-Regulations (GHS).
Executive summary:

The test item was tested for skin irritation on rabbits according to OECD-Guideline No. 404, EU-Testing Method B.4 and in conformity with GLP-principles. The study was performed from November 29 - December 2, 1990.

The test item was found to be non-irritant to rabbit skin. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the European CLP-Regulations (GHS).