α-methylcyclohexanepropanol

Endpoint summary

Description of key information

The acute oral LD50 was determined to be > 2000 mg/kg b.w. in rats.

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:

2003-07-21 to 2003-08-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Shoe:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 140 - 160 g b. w
- Housing: 2-3 per cage, macrolone type III, floor area 810 cm2
- Diet: ad libitum, Altromin 1314 from Altromin, D-32791 Lage, Lippe
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation: 30 min, 2, 4 and 6 h after application and daily for 14 days; weighing: body weight was recorded on day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

No data provided

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

Hunched posture and piloerection for up to 6 h after treatment.

Body weight:

A normal body weight gain was observed.

Gross pathology:

No pathological abnormalities were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in this study with rats was determined to be > 2000 mg/kg b.w..

Executive summary:

An acute oral toxicity using the class method according to OECD 423 was conducted. 2000 mg/kg b.w. of the test substance were administered to 6 female rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. The test substance produced slight signs of toxicity like a hunched posture and piloerection for up to 6 h after treatment. No mortality was observed and the animals showed a normal body weight gain during the study. Therefore the acute oral LD50 in this study was determined to be > 2000 mg/kg b.w. in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The available study is sufficient for assessment.

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

Acute toxicity: Oral route

An acute oral toxicity using the class method according to OECD 423 was conducted. 2000 mg/kg b.w. of the test substance were administered to 6 female rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. The test substance produced slight signs of toxicity like a hunched posture and piloerection for up to 6 h after treatment. No mortality was observed and the animals showed a normal body weight gain during the study. Due to these results the test substance was considered to be practically nontoxic and the oral LD50 > 2000 mg/kg b.w. was derived for rats.

Justification for classification or non-classification

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.