3-methyl-1,3-butandiol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 May - 15 June 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Acute Dermal Toxicity (2-1-2) Nohsan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1,3-butandiol

EC Number:

459-270-7

EC Name:

3-methyl-1,3-butandiol

Cas Number:

2568-33-4

Molecular formula:

C5 H12 O2

IUPAC Name:

3-methylbutane-1,3-diol

Test material form:

liquid

Specific details on test material used for the study:

Appearance: Clear, colourless liquid
Storage conditions: Room temperature in the dark
Lot number: 52834
Expiry: December 2006
Purity: >98%

Test animals

Species:

rat

Strain:

other: Crl:CD BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight to twelve weeks of age
- Weight at study initiation: 221 to 365 g
- Housing: metal cages suspended in mobile stainless steel racks
- Acclimation period:seven days
- Diet: ad libitum
- Water: ad libitum
- Environmental enrichment: small soft white untreated wood blocks during the acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface area
- Type of wrap if used: porous gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30 - 40°C)
- Time after start of exposure: end of 24 hours exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight

Duration of exposure:

24 h

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: The macroscopic appearance of all tissues was recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No deaths occurred and no signs of toxicity were observed.

Gross pathology:

Effects on organs:
No abnormalities were noted in any animal at the macroscopic
examination at study termination on Day 15.

Other findings:

Signs of toxicity (local):
No signs of toxicity or dermal irritation were observed.

Bodyweight gain was reduced in two females on Day 8 and for
one female on Day 15.

Bodyweight was satisfactory in all other animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.
The test substance is in Category 3 according to the EPA Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity testing EPA 712-C-98-189 August 1998.