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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-March-1984 to 02-April -1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study was not conducted under GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chlorododecane
EC Number:
203-981-5
EC Name:
1-chlorododecane
Cas Number:
112-52-7
Molecular formula:
C12H25Cl
IUPAC Name:
1-chlorododecane
Test material form:
liquid
Details on test material:
date of production: 22.02.1985

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Strain: Rabbit / White Russian
- Breeder: Fa. Dr. Karl Thomae GmbH, Biberach
- Number and sex: 6 animals (3 males and 3 females)
- Body weigth: 2 - 2.3 kg
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS:
- Diet: K4 Alleindiat fUr Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: tab water ad libitum
- Housing singly in stainless steel cages
- Temperature: 20°C ± 1°C
- Rel. Humidity: 60% ± 5%
- Light/dark period: 12/12h

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml, undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 3/6/8 days
Score:
2.7
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 3/6/8 days
Score:
2.7
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
other: eschar still present after 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 3/6/8 days
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 3/6/8 days
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
In 2 animals, effects were delayed and occurred 6 to 8 days after treatment.
Other effects:
Yellow staining of the application site was observed in one animal after 24 h to 8 days and in 4 animals at day 6 to 8. Eschar formation was observed in all animals after 10 and 14 days. 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Following 4-hour occlusive treatment with undiluted lauryl chloride, signs for irritancy (erythema/eschar and edema) were observed in all 6 test animals. The mean value (24/48/72 h or 3/6/8 days for the 2 animals showing delayed reactions) for the erythema score is at or above the trigger value for classification of 2.3 in 3 out of 6 animals, and the oedema score is at 2.3 in 2 out of 6 animals. Thus, according to Regulation (EC) 1272/2008 the substance could be classified as non-irritiant, because the triggger value needs to be exceeded in 2 out of 3 animals. Since the trigger value is only nearly missed, and all animals are showing signs of irritiancy (partly delayed) to a different extent accompanied by lasting eschar formation (not fully subsided after 14 days), the test substance is considered to be irritiant to the skin (category 2).