Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Amines, C11-C13 (linear and branched) alkyl
IUPAC Name:
Amines, C11-C13 (linear and branched) alkyl
Details on test material:
- Tridecylamine technical grade
- Purity approx. 95%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.2 kg

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: approx. 0.5 ml
- Concentration: undiluted
Duration of treatment / exposure:
Dorsal skin: 1, 5, 15 minutes and 20 hours
Ear: 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: Dorsal skin and ear

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol 50%

SCORING SYSTEM:
- similar to the table contained in OECD TG 404

Results and discussion

In vivo

Results
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: necrosis

Any other information on results incl. tables

Skin reactions:

After removal of the test substance, bleeding in the skin was observed after 1, 5, 15min exposure.

Time of exposure

Findings after 24 h

Findings after 8 days

Dorsal skin

1 min

N+

N+/ N++ margin: ER++/ED++

5 min

N+

N++/margin: ER++/ED++

15 min

N+

N++/margin: ER++/ED++

20 h

N+/margin: ER++/ED++

N++/margin: ER++/ED++

Ear

20 h

N+++

Mummification

N = necrosis; ER = erythema; ED = edema; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Skin necrosis was seen 48 hours after contact to tridecylamine for 1 (1 out of 2 animals), 5 or 15 minutes or 20 hours.