Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original report not available and documentation is insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The physiological response of animals to some simple mononitroparaffins and to certain derivatives of these compounds
Author:
Machle, W. et al.
Year:
1940
Bibliographic source:
Journal of Industrial Hygiene and Toxicology, Oct. 1940; Vol. 22(3): 315-332

Materials and methods

Principles of method if other than guideline:
To estimate the dermal toxicity of the test substance, an amount was applied to the shaved skin of rabbits and left to dry without covering. The test site was washed after 4 hours. The animals were exposed daily for 5 consecutive days. The skin effects, clinical signs and body weight were monitored during the study period.
GLP compliance:
no
Remarks:
performed prior to GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-amino-2-methylol-1,3-propanediol

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: Animals were housed individually

Administration / exposure

Type of coverage:
open
Vehicle:
not specified
Details on exposure:
TEST SITE
The fur of the animals was clipped closely to the skin of the anterior abdominal wall. The animals were secured and test substance was pipetted onto the clipped skin area. The test substance was left to dry, exposed to the air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was washed with soap and water
- Time after start of exposure: 4 hours
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 hours, for 5 consecutive days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
The test substance was pipetted onto the skin in a 1/16th of an inch (0.16 cm) thick layer. The exact dose is not reported.
Basis:
no data
Control animals:
not specified

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes. Mortality and clinical signs.

DETAILED CLINICAL OBSERVATIONS: No

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION: No

FOOD EFFICIENCY: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

OTHER: No
Sacrifice and pathology:
GROSS PATHOLOGY: No

HISTOPATHOLOGY: No

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY
There was no mortality. No clinical signs were observed.

BODY WEIGHT AND WEIGHT GAIN
No body weight changes were noted.

OTHER FINDINGS
There were no local skin effects.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion