A mixture of cis- and trans-cyclohexadec-8-en-1-one

Endpoint summary

Description of key information

In the key acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10000 mg/kg bw.

 

In the key acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw.

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:

May 1985

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:

1981

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

SPF

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Not specified
- Weight at study initiation: Mean body weights of 205 g
- Fasting period before study: 16 hours before test started
- Housing: In groups of 5 males and 5 females in single cages
- Diet Ad libitum (laboratory standard diet Altromin)
- Water: Ad libitum
- Acclimation period: Not specified
- Microbiological status when known: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 45-55
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 15

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

The test item has been used undiluted after warmed up in a waterbath.

Details on oral exposure:

DOSAGE PREPARATION: The test item has been used undiluted after warmed up in a waterbath.

Doses:

5,000 mg/kg bw and 10,000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours, 48 hours, 7 days and 14 days after dosing
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Appearance and behavior, reflexes, coat, cutaneous turgor, mucosae, faeces, body weights, food and water uptake, acute symptoms

Statistics:

LD50 oral according to Litchfield & Wilcoxon. 24-hours and 14-days LD50 slope function not measurable.

Preliminary study:

Doses were chosen on account of an informational pre-test.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured

Clinical signs:

other: In all dosage groups the preparation did not cause any remarkable symptoms.

Gross pathology:

Slight intestinal hyperaemia in 5 of 10 animals in the highest dosage in final autopsy could be
observed, possibly due to volume. No other macroscopical pathological changes could be observed.

Other findings:

No other findings were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10,000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 and GLP, the test item has been tested after one oral application in the rat. Under the conditions of the experiment, the following results have been determined: The 24 hour-LD₅₀ and 14 days LD₅₀ of the product has been found at higher than 10,000 mg/kg body weight. Body weights did not point to incompatibility. Clinical picture did not show alterations to normal findings. In the final autopsy, no clear anatomic pathological changes occurred. Slight intestinal hyperemia in 5 out of 10 animals in the highest dosage could be observed. Therefore, the product can be considered as nearly harmless (nontoxic).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

> 10 000 mg/kg bw

Quality of whole database:

Reliable without restrictions (RL1)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

1986-08-12 to 1987-03-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

According to OECD 402 and GLP, but individual animal results not provided in the report

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

According to OECD 402 and GLP, but individual animal results not provided in the report.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Young adult
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front. Throughout the 24-hour exposure period the animals were kept in restraining boxes.
- Diet: Ad libitum (standard laboratory rabbit diet), except for 24 hours exposure period
- Water: Ad libitum
- Acclimation period: Approx. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): At least 40
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 15

Vehicle:

unchanged (no vehicle)

Remarks:

The test substance was melted at approx. 35°C

Details on dermal exposure:

TEST SITE
- % coverage: Approx. 10
- Type of wrap used: The treated skin area of the rabbits was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed from the skin with an appropriate solvent.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5 mL/kg bw
- Concentration: The test substance was applied in pure form
- Constant volume or concentration used: No

Duration of exposure:

24 hours

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5 animals per sex were treated with a single dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded on day 0 (day of dosing), 8 and 15 (day of autopsy). Mortality was recorded with the time and cause of death as precisely as possible.
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: All visible reactions to treatment observed during the 24-hour exposure period and during the subsequent two-week period were recorded.
- Other examinations performed: Clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 600 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No rabbits died during the 24-hour exposure period. On day 2, one rabbit was found dead.

Clinical signs:

other: Local effects: During and/or at the end of the 24-hour exposure period treatment-related dermal effects consisted of slight erythema and slight oedema. The following local skin reactions were recorded for all rabbits during the 14-day observation period:

Gross pathology:

The autopsy findings in all animals (also in the animal that died) were normal.

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw.

Executive summary:

A sample of the test substance was examined for its acute dermal toxicity in a limit test with albino rabbits according to OECD guideline 402 and GLP. Five male and five female rabbits were dermally treated with 5.0 mL/kg body weight. The exposure period was 24 hours. Acute local skin reactions consisted of slight erythema and slight oedema. At the end of week 1, moderate to severe scaliness and some slight incrustation were observed, and at the end of week 2 (at autopsy), slight to severe scaliness. The only sign of acute toxicity consisted of slight apathy which was observed in two rabbits. One male rabbit died but autopsy findings were normal. There was some growth retardation during week 1 but during week 2, growth was normal. Apart from the slight local skin effects mentioned above, terminal autopsy findings were normal. On the basis of the results obtained, it was concluded that the substance is not considered to be harmful in contact with skin, the dermal LD₅₀ value being higher than 4600 mg/kg bw (5.0 mL/kg bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

> 4 600 mg/kg bw

Quality of whole database:

Reliable with restrictions (RL2): According to OECD 402 and GLP, but individual animal results not provided in the report.

Additional information

Key, Acute oral toxicity, RL1

In an acute oral toxicity study according to OECD guideline 401 and GLP, the test item has been tested after one oral application in the rat. Under the conditions of the experiment, the following results have been determined: The 24 hour-LD₅₀ and 14 days LD₅₀ of the product has been found at higher than 10,000 mg/kg body weight. Body weights did not point to incompatibility. Clinical picture did not show alterations to normal findings. In the final autopsy, no clear anatomic pathological changes occurred. Slight intestinal hyperemia in 5 out of 10 animals in the highest dosage could be observed. Therefore, the product can be considered as nearly harmless (nontoxic).

 

Key, Acute dermal toxicity, RL2

A sample of the test substance was examined for its acute dermal toxicity in a limit test with albino rabbits according to OECD guideline 402 and GLP. Five male and five female rabbits were dermally treated with 5.0 mL/kg body weight. The exposure period was 24 hours. Acute local skin reactions consisted of slight erythema and slight oedema. At the end of week 1, moderate to severe scaliness and some slight incrustation were observed, and at the end of week 2 (at autopsy), slight to severe scaliness. The only sign of acute toxicity consisted of slight apathy which was observed in two rabbits. One male rabbit died but autopsy findings were normal. There was some growth retardation during week 1 but during week 2, growth was normal. Apart from the slight local skin effects mentioned above, terminal autopsy findings were normal. On the basis of the results obtained, it was concluded that the substance is not considered to be harmful in contact with skin, the dermal LD₅₀ value being higher than 4600 mg/kg bw (5.0 mL/kg bw).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral and dermal toxicity, the test item is not classified and labelled according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.