Registration Dossier

Toxicological information

Skin irritation / corrosion

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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: Study predates OECD guidelines and GLP, not performed in accordance with modern guideline standards, but contributing to overall assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
0.01 ml of undiluted tripropylene glycol was applied to clipped uncovered intact skin of 5 rabbit bellies. Results were scored after 24 hours using a 10 grades system (no injury from undiluted substance = grade 1).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tripropylene glycol
- Substance type: organic
- Analytical purity: not specified
- Lot/batch No.: 06827
- Identification: S-145541
- CHF sample No: 37-61
- Date of receipt: 2-8-74

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
The nonfasted animals were maintained on appropriate Rockland diets and water ad libitum except during period of manipulation or confinement.

Test system

Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.01 ml
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
5

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
10
Reversibility:
no data
Irritant / corrosive response data:
No irritation was observed in 1 animals; moderate capillary injection was observed on 4 rabbits. The overal irritation score was 2 out of 10 (1 = no irritation from undiluted substance).

Applicant's summary and conclusion