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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-04-15 to 1996-05-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
91744-23-9
Molecular formula:
UVCB, not applicable
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Substance type: product
- Physical state: viscous yellow paste
- Purity: 99.8%
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 200 - 300 g
- Fasting period before study: not mentioned
- Housing: conventional, each sex separately, not more than 5 animals/Makrolon cage type III
- Diet (e.g. ad libitum): Ssniff R-10 - Complete feed for rats ad libitum, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not mentioned
- % coverage: approx. 10
- Type of wrap if used: Acrilastik bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and cellulose
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.004 ml/kg
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations 0.5, 1, 2, 3, 4, 5 and 6 hours after application and then daily until day 14 after application; weighing on days 0 (day of application), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: examination of gross macroscopical organ changes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
Number of deaths at each dose: 0/5 male; 0/5 female
Clinical signs:
none, nothing abnormal was detected on the skin in the application area
Body weight:
All animals showed normal development of body weight during the 14-day observation period
Gross pathology:
No alterations related to the test substance were noted
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of was greater than 2000 mg/kg bodyweight. No clinical symptoms occurred.
Executive summary:

The acute dermal toxicity of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) to male and female Sprague-Dawley rats was investigated in a OECD 402 limit test under GLP conditions. The test substance was applied to the skin of five animals per sex in a single dose of 2000 mg/kg bw (semi-occlusive coverage). Total exposure was 24h. Thereafter, the test substance was removed using warm water and cellulose.

Animals were examined for clinical signs 0.5, 1, 2, 3, 4, 5 and 6 hours after treatment. Animals were thereafter daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14 day observation period all animals were subject to necropsy.

During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD0 > 2000 mg/kg bw).