1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 27 to September 10, 1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only 3 animals/sex used, diluted substance (50%), Occlusive patch instead of semi-occlusive. The study was not considered sufficient in its own for acute dermal toxicity endpoint and was therefore used in a weight of evidence assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From August 27 to September 10, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(age at study initiation and some environmental conditions of animal room not reported)

Principles of method if other than guideline:

5 g/kg bw of the experimental material was administered into the stomach of ten rats by means of a syringe and dosing needle.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Sherman-Wistar albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: the rats were deprived of food but not water for 24 hours prior to dosing.
- Housing: not reported
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS: not reported

IN-LIFE DATES: not reported

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not applicable

MAXIMUM DOSE VOLUME APPLIED: not specified

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: daily for observations; once before dosing and once after the observation period for weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

50% test item

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks:

100% test item

Mortality:

None

Clinical signs:

other: - No untoward symptoms were observed during the first 4-6 hours. - After 18 hours the animals were slightly depressed, ruffled and dirty. They appeared recovered and normal within 24-36 hours.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Table 7.2.1/1 Observations

dosage Level g/kg	Number of Animals Dosed	Mortalities Days														Total Dead 14 days	Total Survived 14 days	Avg. Initial Weight g	Avg. Final Weight g
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
5.0	5 males	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	240	275
5.0	5 females	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	225	250

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 Combined (100% test item) > 2500 mg/kg bw. Not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

Executive summary:

In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, a group of Sherman-Wistar strain rats (5/sex) were administered a single oral dose of diluted test material (50%) at 5000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No untoward symptoms were observed during the first 4-6 hours. After 18 hours the animals were slightly depressed, ruffled and dirty. They appeared recovered and normal within 24-36 hours. No abnormalities were noted at autopsy.

Oral LD50 Combined (50% test item) > 5000 mg/kg bw  

Oral LD50 Combined (100% test item) > 2500 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) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

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

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

abraded skin, occlusive dressing and 3 animals/sex used; test material details not given; no details on source, strain, age, housing of animals and environmental conditions of animal room; LD50 calculation method not reported

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

Test material information

Constituent 1

Reference substance name:

1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one

EC Number:

260-486-7

EC Name:

1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one

Cas Number:

56973-85-4

Molecular formula:

C13H20O

IUPAC Name:

1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Test material form:

liquid

Specific details on test material used for the study:

No data

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

PRETREATMENT
All animals had their backs clipped free of hair 24 h prior to testing. All of the animals had their backs abraded prior to dosing.

TEST SITE
- Area of exposure: Test substance was applied to back of each animal.
- Type of wrap if used: Treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data, any excess material was removed.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

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; gross necropsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 days observation period.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks:

50% test item

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

test mat.

Remarks:

100% test item

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

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:

study cannot be used for classification

Conclusions:

This study cannot be used for classification since the test substance was not tested up to limit doses which are relevant for classification according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

The study was not considered sufficient in its own for acute dermal toxicity endpoint.

Executive summary:

In an acute dermal toxicity study (limit test) performed similarly to the OECD Guideline No. 402, the abraded skin of albino rabbits (3/sex) was occlusively exposed to diluted test substance (50%) for 24 h at dose of 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or clinical signs were observed. Surviving animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy.

Dermal LD50 Combined (50% test item) > 2000 mg/kg bw . Thus, Dermal LD50 Combined (100% test item) > 1000 mg/kg bw

This study cannot be used for classification since the test substance was not tested up to limit doses which are relevant for classification according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

The study was not considered sufficient in its own for acute dermal toxicity endpoint.