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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-11-02 to 2011-11-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 Feb, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
EPA 712-C-98-192, Aug., 1998
Deviations:
no
Principles of method if other than guideline:
Method: standard acute method
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyleneglycol dimethacrylate
- Substance type: organic
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: ca. 9 weeks, females: ca. 13 weeks
- Weight at study initiation: males: 231-247 g, females: 217-229 g
- Fasting period before study:
- Housing: full barrier, air-conditioned room, animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre
bedding
- Diet: ad libitum; Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum; tap water, sulfur acidified to a pH value of ca. 2.8
- Acclimation period: at least five days under laboratory conditions

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

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 % of the total body surface
- Type of wrap if used: gauze-dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2000 mg/kg/bw
Duration of exposure:
24 hours
Doses:
Limit test: 2000 mg/kg/bw
No. of animals per sex per dose:
10; 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighted on day 1 (prior to the application) and on day 8 and 15
Clinical examination was made several times on the day of dosing (at least once during the first 30 minutes). Thereafter, clinical signs were
recorded once daily until the end of observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Limit test according to OECD 402.
Mortality:
No mortality observed.
Clinical signs:
Signs of irritation: Erythema grade 2 was observed in 1/5 female animals, erythema grade 1 was observed in 2/5 female animals. Eschar was seen in 2/5 female animals. No signs of irritation were seen in male animals. The observed signs of irritation were reversible within the 14-day observation period.
Body weight:
No treatment-related effects were observed.
Gross pathology:
No treatment-related effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test result: LD50: > 2000 mg/kg bw (OECD 402, GLP) the test substance Ethyleneglycol dimethacrylate has to be classified as practically nontoxic in rats in respect of its acute dermal toxicity (EU GHS criteria; classification based on the criteria of 286/2011/EC).
Executive summary:

In an acute dermal toxicity study (Limit test according to OECD 402), a group of 5 male and 5 female Wistar Crl: WI(Han) rats (source: Charles River, age: 9 weeks (m) and 13 weeks (f), weight: 231 to 247g (m) and 217 to 229 g (f)), were given a single dermal dose of undiluted Ethyleneglycol dimethacrylate (purity: 99.88%) at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.

 

Dermal LD50Males/Females =  > 2000 mg/kg bw

 

Ethyleneglycol dimethacrylate is practically nontoxic in rats based on the dermal LD50in rats. The substance has no toxicity category according to Annex VI to Commission Directive 2001/59/EC, REGULATION (EC) No 1272/2008 and according to OECD GHS criteria.

There were no treatment related signs of mortality or signs of toxicity but signs of irritation. All signs of irritation were reversible within the observation period.

This acute dermal limit test study is classified as acceptable. It does satisfy the requirements for an acute dermal study in the rats according to OECD 402. 

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