4-trans-Pentyl-[1,1-bicyclohexyl]-4-on

Endpoint summary

Description of key information

No mortality was observed in the limit test. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg (reference 7.2-1).

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:

09-04-1991 to 11-06-1991

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:

OECD 1981, Updated Guideline adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Wistar Chbb: THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species: Rat, Wistar Chbb: THOM,
- Sex: males (m) and females (f)
- Age at study initiation: about 7 to 9 weeks
- Source: Thomae, BiberachTEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Mean weight at study initiation: 187 (167 - 205) g
- Fasting period before study: 17 hours prior to dosing until 4 hours after treatment
- Housing: Makrolon cages type III (floor area: 37.5 x 21 cm - 787.5 cm2, height: 15 cm) on mobile racks
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 27
- Humidity (%): 37 - 44
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

other: via stomach tube

Vehicle:

other: 0.25 % aqueous Methocel K 4M Premium solution

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

DOSAGE PREPARATION: 10 g substance mixed in 100 mL vehicle

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 animals per sex - 10 animals in total

Control animals:

yes

Remarks:

10 animals - 5 aniamls per sex

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
observations - for 4 -6 hours after administration and then daily;
weighing - before treatment and on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, gross pathological investigation

Statistics:

The body weight data were processed by means of the program TOX 511 A.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All the rats survived the observation period.

Clinical signs:

other: No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study.

Gross pathology:

In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen.

Median lethal dose (LD50)

Sex	LD50 in mg/kg on days 1+8+15
male	> 2000
female	> 2000

The limit test (2000 mg/kg) showed no mortality, and thus there was no need for a LD50 determination and calculation.

 

Body weight

Body weight
Dose mg/kg	Sex	Animal No.	Values in grams on Day
			1	2	4	6	8	11	13	15
2000	Male	11	167	179	191	212	224	243	252	258
	Male	12	170	189	200	214	225	253	260	267
	Male	13	167	180	199	216	223	248	256	266
	Male	14	174	190	204	220	230	256	267	277
	Male	15	180	191	216	234	251	276	283	283
	Female	16	175	187	194	195	201	206	213	214
	Female	17	181	193	204	213	217	229	228	239
	Female	18	169	180	188	186	193	197	202	198
	Female	19	181	191	199	206	206	212	220	217
	Female	20	183	196	208	215	217	232	228	236
	Males	Number	5	5	5	5	5	5	5	5
		Mean	172	186	202	219	231	255	264	270
		Gain %	****	8	9	8	5	10	4	2
	Females	Number	5	5	5	5	5	5	5	5
		Mean	178	189	199	203	207	215	218	221
		Gain %	****	6	5	2	2	4	1	1

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was observed in the limit test. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Wistar (Chbb: THOM) male and female rats. The test was performed according to OECD 401 "Acute Oral Toxicity" (1987). A limit test with a dose of 2000 mg/kg bw was performed. 5 male and 5 female rats were treated with the limit dose of 200 mg/kg bw. 5 male and 5 female rats were treated with the vehicle as control group. The test item was administered orally via stomach tube, diluted in 0.25 % aqueous Methocel K 4M Premium solution. The animals were observed 4 – 6 hours after administration and then daily for 15 days. Bodyweights were recorded before treatment and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period all animals were anesthetized with CO2 and subjected to complete gross pathology. There were no deaths during the study. No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study. Body weight development of treated and control rats was normal. In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

OECD 401

A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Wistar (Chbb: THOM) male and female rats. The test was performed according to OECD 401 "Acute Oral Toxicity" (1987). A limit test with a dose of 2000 mg/kg bw was performed. 5 male and 5 female rats were treated with the limit dose of 200 mg/kg bw. 5 male and 5 female rats were treated with the vehicle as control group. The test item was administered orally via stomach tube, diluted in 0.25 % aqueous Methocel K 4M Premium solution. The animals were observed 4 – 6 hours after administration and then daily for 15 days. Bodyweights were recorded before treatment and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period all animals were anesthetized with CO2 and subjected to complete gross pathology. There were no deaths during the study. No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study. Body weight development of treated and control rats was normal. In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg (reference 7.2-1).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.