Registration Dossier

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 guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
p-menthane
IUPAC Name:
p-menthane
Constituent 2
Chemical structure
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:
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
Body weight:
within normal ranges
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.