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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 April 2012 to 18 April 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium (2S)-5-oxopyrrolidine-2-carboxylate
Cas Number:
28874-51-3
Molecular formula:
C5H6NO3. Na
IUPAC Name:
sodium (2S)-5-oxopyrrolidine-2-carboxylate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: White to pale yellow powder.
- Storage condition of test material: Controlled room temperature (15-25 °C, below 70 RH %), protected from humidity.

Test animals

Species:
rat
Strain:
other: CRL: (WI)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young rats
- Weight at study initiation: 214 - 266g
- Housing: Individually in polypropylene/polycarbonate cages.
- Diet: Complete diet for rats and mice, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 - 20 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours from 06:00 to 18:00 hours daily.

IN-LIFE DATES: From: 04 April 2012 To: 18 April 2012.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: On the back of each animal.
- % coverage: Approximately 10 % of the whole body surface area.
- Type of wrap if used: The test material was placed onto a gauze pad. The gauze pad was fixed with a hypoallergenic plaster and the entire trunk of the animal was then wrapped with semi occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With body temperature water.
- Time after start of exposure: 24 hours.

TEST MATERIAL
Sufficient water to damp the material was used to ensure good contact with the skin.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical: Observations were performed on the day of treatment at 1 and 5 hours after application of the test material and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Bodyweight: Recorded on Day 0 (before exposure) and on Days 7 and 14.
- Necropsy of survivors performed: Yes, after examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes 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 mortalities were observed in either males or females dosed at 2000 mg/kg bw.
Clinical signs:
No treatment related systemic or local signs of toxicity observed during the 14 day observation period.
Body weight:
Body weight gains of treated animals were within the expected range, and showed no indication of treatment related effects. The mean bodyweight gain for males was 106.6 ± 21.0 g and 26.4 ± 7.7 g for females.
Gross pathology:
No treatment related effects were observed. Bilateral uterine dilatation with clear fluid seen in 2/5 females was regarded as common background.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, no mortalities, systemic or local signs of toxicity were observed in animals treated at 2000 mg/kg bw. The LD50 was therefore considered to be greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was determined in a study conducted under GLP conditions and in line with OECD 402, EU Method B. 3 and EPA OPPTS 870.1200, according to the standard acute method. Five male and five female rats were exposed to the test material in a limit test at 2000 mg/kg bw for 24 hours under an occlusive dressing.

Under the conditions of the study, no mortalities or treatment related systemic or local signs of toxicity were observed in animals treated at 2000 mg/kg bw. The LD50 was therefore considered to be greater than 2000 mg/kg bw.