Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Endpoint summary

Description of key information

Acute oral (OECDTG401): no adverse effect observed.

Acute dermal (OECDTG402): no adverse effect observed.

Acute inhalation (route to route extrapolation): no adverse effect predicted

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 15, 1998 - December 29, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

Limited details on test material, no purity, no details on environmental conditions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Sprague Dawley derived

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USDA License #23-B-009
- Age at study initiation: No data
- Weight at study initiation: males: 238 - 253g; females: 209 - 241g
- Fasting period before study: fasted overnight for approx. 18-24 hours prior to dosing
- Housing: Animals were either single or double housed in suspended stainless steel wire-mesh cages
- Diet: Free access to Agway Prolab 3000
- Water: Free access to city water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS set to maintain
- Temperature (°C): targeted 21
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Individual doses, calculated on the basis of bodyweight and test material density (0.93 g/mL), were administered by syringe and suitable intubation tube.

Doses:

2000 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:
Body weight: just prior to administration and weekly thereafter
Toxicity and mortality: twice daily seven days a week after administration
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male was found dead on day 7.

Clinical signs:

On day 1 in the morning, all animals had decreased locomotion. One female and two males appeared dehydrated therefore all animals were given a water bottle. On day 1, in the afternoon, one female had decreased locomotion, all other animals appeared normal.

Body weight:

All surviving animals showed normal bodyweight increases on the 14th day of the observation period.

Gross pathology:

There were no gross abnormalities in any of the surviving animals. One male was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas.

Interpretation of results:

other: Not classified

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

The acute oral toxicity test with the substance showed an LD50 of >2000 mg/kg bw.

Executive summary:

In this study performed according to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered with the substance at a dose level of 2000 mg/kg bw. One male was found dead on day 7. On day 1 in the morning, all animals had decreased locomotion. One female and two males appeared dehydrated therefore all animals were given a water bottle. On day 1, in the afternoon, one female had decreased locomotion, all other animals appeared normal. There were no gross abnormalities in any of the surviving animals. One male was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 August, 1979 - 10 September, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

No details on test material, no purity, no details on environmental conditions, no details on test animals, abraded skin.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg

ENVIRONMENTAL CONDITIONS
no data

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
All animals had their backs clipped free of hair free of hair 24 hours prior to dosing. All of the animals had their backs abraded prior to dosing.
The test substance was applied to the back of each animal. The 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
The dressing were removed 24 hours after dosing and any excess material was removed and the approximate amount remaining was noted.

No details on the calculation of the individual doses (test material density approximately 1 g/mL).

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: no data
- Bodyweights: at the start and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

Not performed.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

No unusual behavioral signs were noted.

Body weight:

All animals showed gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

The acute dermal toxicity of the substance was >2000 mg/kg bw.

Executive summary:

In this study performed equivalent to OECD TG 402 guideline, 6 rabbits (3 males and 3 females) were administered to the substance at a dose level of 2000 mg/kg bw. No deaths occurred and no unusual behavioral signs were noted. There were no signs of dermal irritation and no abnormalities were noted at necropsy. Based on the results in this study, the acute dermal LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance does not have to be classified for acute toxicity by the dermal route according to Regulation (EC) No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute dermal toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral:

In this study performed according to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered with the substance at a dose level of 2000 mg/kg bw. One male was found dead on day 7. On day 1 in the morning, all animals had decreased locomotion. One female and two males appeared dehydrated therefore all animals were given a water bottle. On day 1, in the afternoon, one female had decreased locomotion, all other animals appeared normal. There were no gross abnormalities in any of the surviving animals. One male was found to have both kidneys dilated, the liver was pale pink, stomach and intestines were distended with gas. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.

Acute inhalation:

Acute inhalation is predicted based on the acute oral toxicity in accordance with the CLP guidance document (2015, page 255). The acute inhalation is predicted to be 5200 mg/m3 and the saturated vapour pressure is 90 mg/m3. This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation is anticipated.

Acute dermal:

In this study performed equivalent to OECD TG 402 guideline, 6 rabbits (3 males and 3 females) were administered to the substance at a dose level of 2000 mg/kg bw. No deaths occurred and no unusual behavioral signs were noted. There were no signs of dermal irritation and no abnormalities were noted at necropsy. The acute dermal LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

Based on the results, the substance does not have to be classified for acute toxicity by the oral, inhalation and dermal route according to Regulation (EC) No. 1272/2008 and its amendments.