1,10-decanediyl diacrylate

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

1,10-decanediyl diacrylate

EC Number:

235-922-4

EC Name:

1,10-decanediyl diacrylate

Cas Number:

13048-34-5

Molecular formula:

C16H26O4

IUPAC Name:

10-(prop-2-enoyloxy)decyl prop-2-enoate

Test material form:

liquid

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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 occurred during the study.

Mortality:

No unscheduled deaths occurred during the study.

Clinical signs:

other: 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.

Body weight:

other body weight observations

Remarks:

Body weight of animals was unaffected by the test item treatment when compared to historical control data (see table 1).

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:

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.

Any other information on results incl. tables

Table 1/Body weight and body weight changes

 

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.

 

Applicant's summary and conclusion

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 is not classified according to the Annex I of the Regulation EC No. 1272/2008 (CLP).

Executive summary:

In an acute dermal toxicity study performed according to OECD Guideline No.402 and in compliance with GLP the test item, 1,10-decanediol diacrylate, 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.

 

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. Therefore, 1,10-decanediol diacrylate is not classified according to the Annex I of the Regulation EC No. 1272/2008 (CLP).