Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study with no information on methods to determine acceptability of study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
No information available.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
EC Number:
224-815-8
EC Name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
Cas Number:
4501-58-0
Molecular formula:
C10H16O
IUPAC Name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
Details on test material:
- Name of test material: Aldehyde Campholenique

Test animals

Species:
rabbit

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
5 g/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Prostration, yellow exudate at nose, ataxia, ptosis, respiratory distress, lethargy, diarrhea, abdomen bloated, emaciated, mucous in stool, alopecia
Other findings:
SKIN IRRITATION
Redness day 1 - none 3/10; severe 7/10
Oedema, moderate - 10/10

Any other information on results incl. tables

Table 1: Necropsy observations

 5.00 g/kg
 Exudate, nose/mouth, yellow  1
Anogenitial, areas yellow  4
 Intestines, bloated  4
 Lungs, areas dark  2
 Kidney, mottled  1
 Lungs, bright orange  3
 Skin, edema  6
 Skin, redness  6
 Skin hard/thick  2

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute dermal toxicity of the test substance was determined to be LD50 >5000 mg/kg.
Executive summary:

In a non-GLP acute dermal toxicity study, the acute dermal toxicity of the test substance was determined to be LD50 >5000 mg/kg.