3-methyl-1,3-butandiol

Endpoint summary

Description of key information

ACUTE ORAL TOXICITY:

LD₅₀: > 5000 mg/kg bodyweight

ACUTE DERMAL TOXICITY:

LD₅₀: > 2000 mg/kg bodyweight

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:

5 March 1987 - 27 March 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: OECD and EPA guidelines and EEC regulations

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

The test material, a clear colourl ess liquid. was stored in the dark under ambient conditions.

Species:

mouse

Strain:

CD-1

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 6-8 weeks old
- Weight at study initiation: 20-30 g
- Fasting period before study: 4-6 hours
- Housing: suspended polypropylene cages wi th stainl ess steel grid tops and with woodshavings for bedding
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

Dose ranging: 100, 500, 1000, 3000 and 5000 mg/kg
Main study: 2000 and 5000 mg/kg

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately prior to dosing, 7 days after dosing and at the end of the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Preliminary study:

No clinical signs were noted at any time after dose administration .
No deaths occurred and no abnormal ities were noted at.gross post mortem examination.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical signs were noted at any time after dose administration.

Gross pathology:

No abnormalities were noted at gross post mortem examination .

Interpretation of results:

GHS criteria not met

Conclusions:

Following acute oral adminstration of the test item to male and female CD-1 mice, no deaths occurred.
It is concluded that the Median Oral lethal Dose (LD50) is greater than 5000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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:

27 May - 15 June 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

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

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%

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

OECD guideline study