1-ethynylcyclohexyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

pre-GLP study, limited documented

Justification for type of information:

Information used for read across to Herbacet #1.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Results derived from a valid read across, with adequate and reliable documentation / justification.

Justification for type of information:

The read across justification is presented in the Acute Toxicity Endpoint summary. The corresponding documentation file is also attached there.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

680 mg/kg bw

Based on:

other: read across information

95% CL:

>= 440 - <= 1 050

Interpretation of results:

other: Acute oral toxicity Category 4

Remarks:

According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The acute oral LD50 for Herbacet #1 is considered to be 680 mg/kg bw, based on read across information from Ambrate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-ethynyl-2-(1-methylpropyl)cyclohexyl acetate

EC Number:

253-378-6

EC Name:

1-ethynyl-2-(1-methylpropyl)cyclohexyl acetate

Cas Number:

37172-05-7

Molecular formula:

C14H22O2

IUPAC Name:

1-ethynyl-2-(1-methylpropyl)cyclohexyl acetate

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No details.

Doses:

300, 600, 1220, and 5000 mg/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 11 days
- Frequency of observations and weighing: No data
- Necropsy performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

680 mg/kg bw

Based on:

test mat.

95% CL:

>= 440 - <= 1 050

Mortality:

300 mg/kg bw: 2/10 died; deaths were observed on day 1 and day 3.
600 mg/kg bw: 4/10 died; deaths were observed on day 1 (3 animals) and on day 11 (1 animal).
1220 mg/kg bw: 8/10 died; deaths were observed on day 1 (4 animals), day 2 (3 animals) and on day 10 (1 animal).
5000 mg/kg bw: 10/10 died; deaths were observed on day 1 (7 animals) and on day 2 (3 animals).

Clinical signs:

other: 300 mg/kg bw: no clinical signs were observed. 600 mg/kg bw: lethargy, ptosis and piloerection. 1220 mg/kg bw: flaccid tone. 5000 mg/kg bw: lethargy, ataxia and coma.

Gross pathology:

Necropsy observations:
300 mg/kg bw: Intestines, red areas (1/10); intestines, yellow areas (2/10); liver, mottled (2/10); lungs, dark areas (4/10); kidneys dark (2/10)
600 mg/kg bw: Exudate, nose/mouth (1/10); intestines, yellow areas (3/10); intestines, bloated (1/10), liver dark (2/10); liver, mottled (3/10); lungs dark (1/10); lungs, dark areas (3/10); kidneys dark (3/10); kidneys, mottled (3/10); spleen large (1/10).
1220 mg/kg bw: Exudate, nose/mouth (1/10); exudate, anogenital (2/10), intestines, red areas (1/10); intestines, yellow areas (5/10); liver dark (2/10); liver, mottled (4/10); lungs dark (1/10); lungs, dark areas (4/10); kidneys dark (6/10); kidneys, mottled (2/10); spleen large (2/10).
5000 mg/kg bw: Exudate, nose/mouth (10/10); exudate, anogenital (3/10); intestines, red areas (1/10); intestines, yellow areas (10/10); intestines, bloated (7/10), liver, mottled (10/10); lungs dark (10/10); kidneys dark (10/10); blood in bladder (3/10).

Applicant's summary and conclusion

Interpretation of results:

other: Acute oral toxicity Category 4

Remarks:

According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The acute oral LD50 in rats was determined to be 680 mg/kg bw.

Executive summary:

In an acute oral toxicity study, performed similar to OECD TG 401 (pre-OECD, pre-GLP, rated Klimisch 2), 4 groups of 10 rats were orally exposed to the test substance and observed for signs of toxicity for a period of 11 days. At 300, 600, 1220 and 5000 mg/kg bw, respectively 2/10, 4/10, 8/10 and 10/10 animals died. Deaths occurred on day 1, 2, 3, 10 and 11. Clinical signs observed were lethargy, ptosis, piloerection, flaccid tone, ataxia and coma. At necropsy following effects were observed: exudate from nose/mouth and anogenital exudate, in the intestines red and yellow areas were observed and bloated intestines, dark livers and mottled livers, dark lungs and dark areas in the lungs, dark kidneys and mottled kidneys, large spleens, and blood in the bladder. Based on the results, a LD50 of 680 mg/kg bw was obtained in the acute oral toxicity study with rats.