1-isopropyl-4-methylcyclohexane

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

p-menthane

IUPAC Name:

p-menthane

Constituent 2

Reference substance name:

1-isopropyl-4-methylcyclohexane

EC Number:

202-790-4

EC Name:

1-isopropyl-4-methylcyclohexane

Cas Number:

99-82-1

Molecular formula:

C10H20

IUPAC Name:

1-methyl-4-(propan-2-yl)cyclohexane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): para-Menthane (p-Menthane)
- Physical state: colourless liquid

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.