Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Palmitic acid
EC Number:
200-312-9
EC Name:
Palmitic acid
Cas Number:
57-10-3
IUPAC Name:
palmitic acid
Constituent 2
Reference substance name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
IUPAC Name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Züchter Fa. Thomae, Biberach, Germany
- Weight at study initiation: mean: 2452.5g
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12712

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5g

Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
4
Details on study design:
The substance Edenor C16 was tested in undiluted form for primary skin irritation. 0.5 g of the product were applied to a 2.5 cm x 2.5 cm linen cloth and evenly distributed on the linen cloth. The linen cloth were placed on the shaved back skin of the rabbits and covered with a large plastic foil, which was fixed at the edges with tape. To achieve a secure fixation and an occlusive cover all was covered with acrylastic band. The duration of treatment was 4 hours and the observation period 3 days.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No skin reactions were observed.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin reactions were observed.
Executive summary:

The substance Edenor C16 was tested for its primary skin irritation under occlusive conditions on the shaved back skin of 4 rabbits according the OECD guideline 404.

After a contact time of 4 hours the skin reactions were evaluated.

No skin reactions were observed.

Therefor the substance Edenor C16 is not irritating.