1,10-decanediyl bismethacrylate

Endpoint summary

Description of key information

The potential of acute toxicity of 1,10-decanediol diacrylate was evaluated in two studies, one by oral route and one by dermal route. No mortalities were showed in both studies; the oral and dermal LD50 were higher than 5000 and 2000 mg/kg in rats, respectively. 

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:

March - April 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 9 weeks
- Weight at study initiation: males = 224-250g ; females = 160 -197 g
- Fasting period before study: yes
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The preparation was made immediately prior to dosing.
The animals received the test article on a mg/kg bw base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was agin presented approximately one hour after dosing.
Volume d'application = 20 ml

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations : four times during test day 1, and daily during days 2-15
- Frequency of weighing: on day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes

Statistics:

no

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality

Clinical signs:

No signes of symptoms observed

Body weight:

No change

Gross pathology:

No macroscopic organ changes were observed

Other findings:

no

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of Decanemethylendimethacrylate in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg.

Executive summary:

The test article decanemethylendimethacrylate was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg.

No death, no clinical signs, no change of body weight and no macroscopic changes were observed.

Indeed, the acute oral toxicity of Decanemethylendimethacrylate in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The oral acute study is considered to be a reliable study (klimisch score of 1).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

15 April 2013 - 13 June 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: the males had a mean body weight of 352 g (range: 340 g to 361 g) and the females had a mean body weight of 233 g (range: 223 g to 243 g).
- Fasting period before study: yes, during the night before treatment
- Housing: polycarbonate cages
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 21 May 2013 to 07 June 2013

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage

REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: none

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume: no

Duration of exposure:

24h

Doses:

2000 mg/kg

No. of animals per sex per dose:

ten rats (five males and five nulliparous and non pregnant females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight on the day of group allocation: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).

Statistics:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (no mortality)

Mortality:

No unscheduled deaths occurred during the study.

Clinical signs:

Chromodacryorrhea was observed in 1/5 males on days 7 and 8. As this clinical sign was of isolated occurrence, this was considered as incidental.
Erythema (very slight to severe) and edema (very slight or slight) were noted on application site of all male and female animals from day 2 up to day 7 at the latest.
These findings were associated with dryness of the skin (very slight or slight) at application site of all males and at application site of 4/5 females from day 4 up to day 15 at the latest.
In addition, desquamation was noted in 2/5 females from day 4 to day 13 or 14.
Scabs on application site were also observed in 1/5 males and 1/5 females between day 5 and day 7.

Body weight:

The mean body weights and the mean body weight changes (g) recorded in test item-treated animals during the observation period and in historical control data are summarized in the Table 1.
Body weight of animals was unaffected by the test item treatment when compared to historical control data.

Gross pathology:

There were no findings considered to be related to the test item administration.
The few macroscopic findings noted at the end of the treatment period (deformation and strangling of the spleen in a single male at 2000 mg/kg) were considered to be fortuitous.

Other findings:

no

Table 1. 

Sex	Female		Male
Group	historical control data	1	historical control data	2
Dose-level (mg/kg)	0	2000	0	2000
Body weight (mean (± SD))
. Day 1	236 (± 8.9)	233 (± 8.1)	362 (± 12.0)	352 (± 7.9)
. Day 8	253 (± 12.0)	250 (± 8.2)	394 (± 15.3)	383 (± 9.6)
. Day 15	273 (± 16.3)	275 (± 8.4)	441 (± 21.5)	430 (± 14.9)
Body weight change (mean (± SD))
. Days 1-8	+17 (± 11.0)	+18 (± 8.6)	+32 (± 9.1)	+31 (± 3.6)
. Days 8-15	+20 (± 7.1)	+25 (± 2.8)	+47 (± 7.5)	+47 (± 7.2)
. Days 1-15	+37 (± 16.3)	+42 (± 6.5)	+79 (± 15.6)	+78 (± 9.5)

SD: standard deviations.

 

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the dermal LD50 of 1,10-decanediol diacrylate was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as harmful or toxic by dermal route according to the criteria of CLP Regulation.

Executive summary:

The objective of this study was to evaluate the potential toxicity of 1,10-decanediol diacrylate following a single dermal application to rats.

This study was conducted in compliance with OECD Guideline No. 402 and the principles of Good Laboratory Practices.

Methods

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15.

On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.

Results

No unscheduled deaths occurred during the study.

No clinical signs indicative of systemic toxicity were observed in any animals.

 

Erythema and edema were noted on application site of all male and female animals from day 2 up to day 7 at the latest. These findings were associated with dryness of the skin at application site of all males and at application site of 4/5 females from day 4 up to day 15 at the latest.

In addition, desquamation was noted in 2/5 females from day 4 to day 13 or 14.

Scabs on application site were also observed in 1/5 males and 1/5 females between day 5 and day 7.

Body weight of animals was unaffected by the test item treatment when compared to historical control data.

The test item administration did not induce any macroscopic findings at necropsy.

Conclusion

Under the experimental conditions of this study, the dermal LD50 of 1,10-decanediol diacrylate was higher than 2000 mg/kg in rats.

Therefore, the test item should not be classified as harmful or toxic by dermal route according to the criteria of CLP Regulation. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study is considered to be reliable with a klimisch score of 1.

Additional information

Acute oral toxicity (Ullman 1986):

The test article decanemethylendimethacrylate was administered to rats of both sexes by oral gavage, at a dose of 5000 mg/kg (OECD 401).

No death, no clinical signs, no change of body weight and no macroscopic changes were observed.

Indeed, the acute oral toxicity of Decanemethylendimethacrylate in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg.

Acute dermal toxicity (read-across, Papineau 2013):

The objective of this study was to evaluate the potential toxicity of 1,10-decanediol diacrylate following a single dermal application to rats.

This study was conducted in compliance with OECD Guideline No. 402 and the principles of Good Laboratory Practices.

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

No unscheduled deaths occurred during the study. No clinical signs indicative of systemic toxicity were observed in any animals.

Erythema and edema were noted on application site of all male and female animals from day 2 up to day 7 at the latest. These findings were associated with dryness of the skin at application site of all males and at application site of 4/5 females from day 4 up to day 15 at the latest.

In addition, desquamation was noted in 2/5 females from day 4 to day 13 or 14.

Scabs on application site were also observed in 1/5 males and 1/5 females between day 5 and day 7.

Body weight of animals was unaffected by the test item treatment when compared to historical control data.

The test item administration did not induce any macroscopic findings at necropsy.

Under the experimental conditions of this study, the dermal LD50 of 1,10-decanediol diacrylate was higher than 2000 mg/kg in rats.

Justification for classification or non-classification

No mortality or severe clinical signs was observed in the oral and dermal acute toxicity study performed at the limit dose. No toxicity is expected after inhalation exposure.

Therefore 1,10 -decanediyl bis methacrylate is not classified for acute toxicity according to the Regulation EC no.1272/2008.