Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 13 to 27, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401 with minor deviations that do not affect the reliability of the study.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no details test animals and environmental conditions)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
(pre-GLP)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-pentylcyclopentan-1-one
EC Number:
225-392-2
EC Name:
2-pentylcyclopentan-1-one
Cas Number:
4819-67-4
Molecular formula:
C10H18O
IUPAC Name:
2-pentylcyclopentan-1-one
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): P1078/2
- Density: Approximately 1 g/mL

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: Animals were fasted for 24 h before test material administration.
- Diet: Food, ad libitum
- Water: Water, ad libitum

IN-LIFE DATES: From: November 13, 1978 To: November 27, 1978

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
- No mortality was observed.
Clinical signs:
- Animals were ruffled and depressed within 2 h after dosing but were normal after 24 h.
Body weight:
- All animals showed expected gains in bodyweight over the 14-day study period.
Gross pathology:
- No abnormalities were noted at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 Combined > 5000 mg/kg bw
Executive summary:

In an acute oral toxicity study (limit test) performed similarly to OECD Guideline No. 401, a group of Sherman-Wistar rats (5/sex) were administered a single oral dose of test material at 5000 mg/kg bw by gavage. Animals were observed for mortality and clinical signs daily for 14 days. Initial and final body weight of the animals were recorded and then necropsied for macroscopic observations.

No mortality was observed. Animals were ruffled and depressed within 2 h after dosing but were normal after 24 h. All animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy.

Oral LD50 Combined > 5000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.