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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Short summary and overall relevance of the provided information on acute oral toxicity

Animals selected for the study were randomised by weight and group allocated. The method used to investigate the acute oral toxicity of 3-methyl-1,3 -butanediol acetate was the acute oral fixed procedure (OECD 420 (2001)).The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.

 

No clinical signs of toxicity or mortality were observed in rats in the sighting or main study. Body weight gain of these animals was normal. No treatment related gross pathological findings were noted in the animals.

 

Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.

 

Short summary and overall relevance of the provided information on acute inhalation toxicity

Not relevant for REACh Annex VII, tonnage band 1-10.

 

Short summary and overall relevance of the provided information on acute dermal toxicity

Not relevant for REACh Annex VII, tonnage band 1-10.

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:
2016-01-14 to 2016-02-10 (experiment start-end)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
(2001)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Kuraray Co. Ltd. IPDA-63313
- Expiration date of the lot/batch: 30 March 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark under nitrogen
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: one dose formulation prepared at 30 mg/mL. To achieve a 200 mg/mL dose, the test article was used as supplied
- Final preparation of a solid: n/a
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 wks
- Weight at study initiation:
- Fasting period before dosing: overnight, followed by 3-4 h post dosing
- Housing: gp housed (up to 4/cage)
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet, ad libitum
- Water (e.g. ad libitum): municpal water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 14 January 2016 to 10 February 2016
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): dose volume 10 mL
- Justification for choice of vehicle: suitable vehicle for oral gavage studies
- Lot/batch no. (if required): not stated
- Purity: n/a

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a starting dose of 300 mg/kg bw was used in the sighting study as recommended by the OECD TG 420
Doses:
300 mg/kg bw
2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw: 1 females
2000 mg/kg bw: 5 females
Control animals:
no
Details on study design:
The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.
Statistics:
None
Preliminary study:
A sighting study was undertaken, where a single female rat was dosed, orally via gavage at 300 mg/kg bw.
No mortality, or signs of clinical toxicity were observed.
The single animal treated showed expected body weight gains over the observation period.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No signs of clinical toxicity were observed
Gross pathology:
No macroscopic changes were observed
Other findings:
Histopathology and organ weights not undertaken
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.
Executive summary:

Animals selected for the study were randomised by weight and group allocated. The method used to investigate the acute oral toxicity of 3 -methyl-1,3 -butanediol acetate was the acute oral fixed procedure (OECD 420 (2001)), conducted under GLP.The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.

No clinical signs of toxicity or mortality were observed in rats in the sighting or main study. Body weight gain of these animals was normal. No treatment related gross pathological findings were noted in the animals.

Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
1 (reliable without restrictions) GLP, guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Comparison with the CLP criteria

Oral

The acute oral LD50 in the rat of 2000 mg/kg bw for females exceeds the value for which classification for acute oral toxicity is required (i.e. > 2000 mg/kg bw). Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 3-methyl-1,3 -butanediol acetate has no obligatory labelling requirement for acute oral toxicity and is unclassified.

 

The test article, 3-methyl-1,3 -butanediol acetate does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic toxicity was observed.

 

Dermal 

Not relevant for REACh Annex VII, tonnage band 1-10

 

Inhalation

Not relevant for REACh Annex VII, tonnage band 1-10.

 

Overall conclusion

In accordance with the ECHA Chapter R.7a guidance, 3-methyl-1,3 -butanediol acetate in not toxic via the oral route and no evidence of systemic toxicity has been observed. Consequently, the need to classify for this endpoint is not triggered