3-methoxy-3-methylbutan-1-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-05-07 to 1991-05-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Guideline:

other: Meeting Japanese MAFF (Ministry of Agriculture, Forestry and Fisheries) Testing Guidelines for Toxicity Studies (28 Januar 1985, 59 NohSan No. 4200) - Acute Dermal Toxicity Study

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxy-3-methylbutan-1-ol

EC Number:

260-252-4

EC Name:

3-methoxy-3-methylbutan-1-ol

Cas Number:

56539-66-3

Molecular formula:

C6H14O2

IUPAC Name:

3-methoxy-3-methylbutan-1-ol

Details on test material:

- Name of test material (as cited in study report):3-methoxy-3-methyl-1-butanol
- Molecular formula: C6H14O2
- Molecular weight: 118
- Physical state: colorless clear liquid
- Analytical purity: 99.19 wt%
- Impurities (identity and concentrations):
- Purity test date:
- Lot/batch No.:22517
- Stability under test conditions: no special reactivity, stable , because IR spectrum had not changed (IR-tested)
- Storage condition of test material: stored in refrigerator
- Other:Supplier was MOE (supplied by Kuraray Co., LTD.), supplied volume 100 mL, obtained 30-10-2001, melting point -50°C, water solubility: arbitrarily soluble

Specific details on test material used for the study:

Solfit (proprietary name)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 204 - 324 g
- Housing: Housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 5 animals per cage
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Maintenance Diet, available ad libitum
- Water (e.g. ad libitum): Tap water, available ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 51%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700 - 1900 h)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 23 cm^2
- Type of wrap if used: The test material was applied evenly onto a gauze dressing which was applied to the shaved back. The trunk of the rat was then encircled with a strip of non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was wiped with a water dampened tissue
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500, 1000, 1500 and 2000 mg/kg for the range finding study; 2000 mg/kg for the main test

Duration of exposure:

24 hours

Doses:

500, 1000, 1500 and 2000 mg/kg for the range finding study; 2000 mg/kg for the main test

No. of animals per sex per dose:

2 in the range finding test
5 in the main test

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: They were weighed immediately prior to dosing, 7 days after dosing (main study only) and at sacrifice at the end of the 14 day observation period
- Necropsy of survivors performed: yes (sacrifice by carbon dioxide asphyxiation)
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

In the dose ranging study there were no deaths and no abnormalities were noted at necropsy. Clinical signs, noted 2-4 h after dosing, were limited to reduced activity.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no Mortality

Clinical signs:

other: no clinical signs

Gross pathology:

No abnormalities were detected at necropsy.

Any other information on results incl. tables

Solfit: Acute Dermal Toxicity (LD50) Test in Rats; Test Results 2000 mg/kg

Animal/Sex	Mortality	Clinical Signs	Necropsy Findings
17¿	0	NAD	NAD
18	0	NAD	NAD
19	0	NAD	NAD
20	0	NAD	NAD
21	0	NAD	NAD
22¿	0	NAD	NAD
23	0	NAD	NAD
24	0	NAD	NAD
25	0	NAD	NAD
26	0	NAD	NAD

NAD = No abnormalities detected

Solfit: Acute Dermal Toxicity (LD50) Test in Rats; Body Weight 2000 mg/kg

Animal/Sex	Body Weight (g)
	At Dosing	After 7 days	After 14 days	Gain (Loss)
17¿	287	332	370	83
18	281	318	340	59
19	297	330	360	63
20	324	369	404	80
21	284	326	355	71
Mean	295	335	365	71
± S.D.	18	20	24	10
22¿	204	232	227	23
23	227	237	234	7
24	227	244	241	14
25	220	241	226	6
26	231	249	240	9
Mean	222	241	234	12
± S.D.	11	7	7	7

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The Median Dermal Lethal Dose (LD50) of Solfit in rats is greater than 2000 mg/kg

Executive summary:

The acute dermal toxicity potential of Solfit was investigated in rats. A dose ranging study in pairs of rats indicated that the LD50 value by dermal route is greater than 2000 mg.kg^-1. A main study dose level of 2000 mg. kg^-1 was selected accordingly. No further testing at other dose levels was necessary. In the main study, no deaths occurred and no clinical signs were noted after a 24 h dermal administration, under occlusion, of Solfit at a dose level of 2000 mg.kg^-1. The median Dermal Lethal dose (LD50) of Solfit in rats is greater than 2000 mg.kg^-1.