[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 12 Sep 2007 to 29 Nov 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to an international test guideline and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks for males and 11 weeks for females
- Weight at study initiation: approximately 250 g for males and 200 for females
- Fasting period before study: No
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum. Results of analyses for contaminants will be archived at RCC Ltd.
- Water (e.g. ad libitum):Community tap-water, from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses will be archived at RCC Ltd.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the daytime light period)

IN-LIFE DATES: From 20 sep 2007 to 04 Oct 2007

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back of the animals
- % coverage: 10% of the total body surface
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.90 mL/kg bw
- Concentration (if solution): 1.0553 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily during the acclimatization period, at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
- Frequency of weighing:On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded. Local signs: Once daily during days 2-15. All abnormalities were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study.

Clinical signs:

other: No clinical signs were observed during the observation period.

Gross pathology:

Effects on organs: No macroscopic findings were recorded at the scheduled necropsy.

Other findings:

Signs of toxicity (local):
At removal of the patch, no local signs were observed in any animal. However, on test day 5, one female exhibited a slight local erythema. Additionally, slight scaling was recorded at the same observation time point up to day 8 (in the same female). Otherwise, no local reactions were observed in any other animal up to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not harmul by the dermal route.

Executive summary:

In an acute dermal toxicity study ((RCC 2007 study n° B31195), 5 male and 5 female Wistar rats were dermally exposed to undiluted Dimethyl 2-methyl glutarate for 24 hours to 10% of body surface area at the dose of 2000 mg/kg bw.  Animals were then observed for 14 days.

 

Dermal Combined LD₅₀> 2000  mg/kg bw.

Dimethyl 2-methyl glutarate is not classified based on the LD₅₀.

 

No mortality and no clinical signs were noted during the study. No local signs were observed in any animal except for one female which exhibited a slight local erythema on day 5 and a slight scaling from days 5 to 8. There was no effect on body weight gain.

 

This acute dermal study is classified as acceptable.  It does satisfy the guideline requirement for an acute dermal study (OECD402) in the rat.