1-isopropyl-4-methylcyclohexane

Endpoint summary

Description of key information

The oral LD50 in rats is >3000 mg/kg bw (Hüls 1989). The dermal LD50 in rats is > 2000 mg/kg bw (TC 2012).

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:

2/3 to 17/3 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: similar to guideline study, non-GLP and no individual data reported

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Wilmslow Wistar
- Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: average 153 g
- Fasting period before study: 16 hours before application
- Housing: 5 animals/macrolon III cage
- Diet: R10 allein diät Ssniff laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: 5 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5%
- Air changes (per hr):15/hr
- Photo period (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-03-1989 To: 17-03-1989

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: NA

MAXIMUM DOSE VOLUME APPLIED: 3.75 cm³/kg bw

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: until 6 hours and daily thereafter
Body weight:on day 0, 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: macrocopic investigations

Statistics:

NA limit test

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: ventro-lateral recumbency, piloerection and diarrhea in males during first 24 hours.Thereafter, no observations.

Gross pathology:

thickening of the forestomach mucosa

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 in rats is >3000 mg/kg bw

Executive summary:

In a limit test rats received 3000 mg/kg bw of the test substance. No mortality occurred. The LD50 is >3000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Quality of whole database:

The LD50 is > 3000 mg/kg bw

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:

03-10-2012 to 18-10-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to guideline under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Not indicated
- Weight at study initiation: Males 268 - 280 g; females 225 - 231 g
- Fasting period before study: NA
- Housing: 1/cage in Type II polypropylene/polycarbonate cages
- Diet: ssniff® SM R/M-Z+H complete diet ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 03-10-2012 To: 18-10-2012

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of body surface
- Type of wrap if used: semi occlusive gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with water
- Time after start of exposure: 24 hours

TEST MATERIAL: 2000 mg/kg bw

Duration of exposure:

24 hours with a 14 day observation period

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
mortality twice daily;
clinical signs at 1 and 5 hours after removal of the dressing, daily thereafter
body weight on day 1 (before treatment), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

NA limit test

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: local effects related to irritation (all reversible at day 7) : redness 3/5 males desquamation 1/5 males; 1/5 females crustiness: 2/5 males

Gross pathology:

hydrometra in 2/5 females

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for dermal toxicity is >2000 mg/kg bw

Executive summary:

A single dose of the test substance at 2000 mg/kg bw was applied dermally to rats (5/sex). Signs of toxicity were limited to local irritant effects that were fully reversible after day 7. The LD50 for dermal toxicity is >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The LD50 is > 2000 mg/kg bw

Additional information

No toxicity after acute oral and dermal exposure was observed.

Justification for selection of acute toxicity – oral endpoint
similar to guideline study, non-GLP and no individual data reported

Justification for selection of acute toxicity – dermal endpoint
study under GLP according to the guideline

Justification for classification or non-classification

The substance does not need to be classified for acute toxicity. Based on the viscosity data available (kinematic viscosity 1.107 mm²/s at 40°C) the substance needs to be classified as H304.