1,6-hexanediyl bismethacrylate

Endpoint summary

Description of key information

1,6-Hexanediol dimethacrylate is of low acute oral toxicity. LD50 is higher than 2000 mg/kg bw in rats. 
Acute oral toxicity: LD50 (rat, combined) > 2000 mg/kg bw; OECD Guideline 423, GLP (Klimisch score = 1)
Acute inhalation toxicity: no relevant route of exposure
Acute dermal toxicity: no relevant route of exposure

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22 March, 1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species: rats (HsdBrl:WH,Full-Barrier, SPF)
- Source: Harlan Winkelmann GmbH, D-33178 Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: female 151-157 g and male 165-172 g
- Fasting period before study: Prior to administration of the test item animals were fasted by withholding food over-night Following the period of
fasting the animals were weighed and the test substance was administered. Then the food was withhold for a further 3-4 hours.
- Housing: animals were individually kept in Macrolon cages on Altromin saw fiber bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water: ad libitum, tap water (drinking water, municipal residue control, microbial. controlled periodically)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 °C
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): Lot 65 H 0629
- Purity: no data, commercial grade assumed (Sigma Chemicals)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

The starting dose was 2000 mg/kg body weight. Since no presence of compound-related mortality of the animals was observed no further testing was required.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed prior to first application and once a week there­after.
- Necropsy of survivors performed: yes
- Other examinations performed: A careful clinical examination was made once a day.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality and clinical signs observed

Mortality:

No compound related mortalities observed up to the oral application of 2000 mg/kg/bw.

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period, except a reduced activity until 1 hour after dosing with all animals This reduction in activity is caused by the manipulation and oral gavage, respectively. 3 hours after dosin

Gross pathology:

Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
No other macroscopic necropsy findings were observed.

Body weight gain

 

 

Animal No. Sex	Day O	Day 7	Day 14
1 male	172	224	260
2  male	165	213	258
3  male	172	227	263
1 female	151	166	177
2  female	157	168	192
3  female	156	172	192

Interpretation of results:

GHS criteria not met

Conclusions:

According to the test result according to OECD guideline 423 (acute toxic class method): LD50(14days) > 2000 mg/kg bw the test substance 1,6-Hexanedioldimethacrylate has to be classified as nontoxic in respect of its acute oral toxicity (EU). According to OECD GHS the substance is to be classified.

Executive summary:

In an acute oral toxicity study according to OECD guideline 423 (acute toxic class method), a group of male and female Wistar rats were given a single oral (gavage) dose of 1,6 -Hexanedioldimethacrylate at a dose of 2000 mg/kgbw and observed for 14 days.

A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes.

A maximum dosage of 2000 mg/kg BW according to the acute toxic class method regime, caused no compound related mortality within 14 days post application. No clinical signs of toxicity were observed throughout the observation period.

 

Therefore the oral LD₅₀ (combined) was determined to be > 2000 mg/kg bw.

OECD GHS Category 5 ranges from 2000 - 5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).

    

Based on the results of this study ( LD50 acute toxic class test in male and female rats) 1,6 -Hexanedioldimethacrylate is not classified according to EU-GHS and according to OECD GHS criteria Category 5.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

There is one relevant, adequate and reliable study for 1,6-Hexanediol dimethacrylate available (BSL, 1997) (Klimisch score = 1) The test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study OECD 423, GLP.

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

1,6-Hexanediol dimethacrylate is of low acute oral toxicity.

LD50: > 2000 mg/kg bw (oral rat, acute toxic class method). The acute oral LD50 is found to be higher than 2000 mg/kg bw in rats in absence of mortality and clinical signs. Therefore 1,6 -Hexanediol dimethacrylate has no acute toxic characteristics by oral route (BSL, 1997).

Justification for classification or non-classification

Based on the available oral data LD50 is higher than 2000 mg/kg bw in rats, 1,6 -Hexanediol dimethacrylate is not classified according to Annex I of CLP/EU-GHS (1272/2008/EC) and UN GHS.