Registration Dossier

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:
other: Gudeline study OECD 402, GLP.

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
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Ethyltriglycol methacrylate
- 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: 236-249 g, females: 208-220 g
- Fasting period before study: no
- 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 (drinking water, municipal residue control, microbiological controls at regular intervals)
- 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk, approx. 10 % of the total body surface
- % coverage: 10 % of the total body surface
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with additional dressing in suitable manner.

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
- Concentration (if solution): n/a (undiluted)
- Constant volume or concentration used: yes (single dose)
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:
other: Untreated skin areas of the test animals serve as the control
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, gross pathological changes
-- In case of gross pathological changes, tissues were preserved for a possible histopathological evaluation.
-- The treated areas of skin were examined daily for signs of primary skin irritation. Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404, adopted 24th April 2002.

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: mortality 0/10 Limit test according to OECD 402.
Mortality:
No mortality observed. All animals survived until the end of the observation period of 14 days.
Clinical signs:
No signs of systemic toxicity were observed.
The nasal discharge observed 1 day post-dose in one female animal is not considered to be related to the test item, but to the administration
procedure and the possible stress induced.
Signs of irritation: Erythema grade 1 was observed in 2/5 female animals at day 2 and 3, the 2 animals recovered at days 4 to erythema grade 0. No signs of irritation were seen in male animals. The observed signs of irritation were reversible within the 14-day observation period.
Body weight:
A slight weight loss was recorded for 1 of 5 female animals during the first week, but all of the female animals showed weight gain during the
second week, The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation.
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
According to the test result: LD50: > 2000 mg/kg bw (OECD 402, GLP) the test substance Ethyltriglycol methacrylate 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: 236 to 249g (m) and 208 to 220 g (f)), were given a single dermal dose of undiluted Ethyltriglycol methacrylate (purity: 98.95%) at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.

 

Dermal LD50Males/Females =  > 2000 mg/kg bw

 

Ethyltriglycol methacrylate 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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