Registration Dossier

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:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions. Documentation is brief, and observations at 48 and 72 h after treatment as required by OECD 404 were not conducted. However, the necrosis persisted and aggravated within 8 days even at the sites that had only short contact to the test substance. Therefore, these restrictions are acceptable and do not invalidate this study.

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tridecylamine, mixture of isomers, technical grade (approx.
95%)

Test animals

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

Test system

Type of coverage:
other: occlusive, open during the short term exposures
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

Any other information on results incl. tables

Skin reactions:

Time of exposure

Findings after 24 h

Findings after 8 days

Dorsal skin

1 min

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

Dorsal skin reactions 24 h post treatment:
Distinct necrosis of dorsal skin was noted 24 h after application irrespective of duration of exposure. Severe erythema and edema was additionally noted at the sites exposed for 20 h.

Skin reactions 8 days post treatment:
After 8 days severe skin necrosis was noted at the sites exposed for 5 minutes or longer. Slight necrosis and severe erythema and edema was noted at the sites which had contact with TS for one minute.
The rabbit's ear skin reactions were more severe. A very pronounced necrosis was seen after 24 h, and mummification after 8 days.

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information (causes severe burns)
Conclusions:
Dorsal skin necrosis was seen at 1 and 8 days following
contact to tridecylamine for 1, 5 or 15 minutes or 20 hours.