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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:
November 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester
- Physical state: liquid
- Storage condition of test material: Room temperature, protected from light in the tightly closed original container

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: "Nossan" - Correzzana MI - ITALY
- Age at study initiation: no data
- Weight at study initiation: 180 - 200 g
- Fasting period before study: no data
- Housing: groups of 5 of the same sex in transparent polycarbonate cages (dimensions mm 425X266X180)
- Diet: standard pellet complete diet supplied by the breeder
- Water: Filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1993-11-17 To: 1993-12-1

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: no data
- Type of wrap if used: The sample was put on a patch (Hansamed strips), the patch was then covered by an impermeable and hypoallergenic plastic adhesive tape (Blenderm 3M)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General conditions of the animals were controlled after 2, 6 and 24 h and daily thereafter for 14 days, observations included: mortality, clinical signs and behaviour (somatic motor activity, tegumentary apparatus, mucosae conditions, respiratory activity, sensorium conditions), weighing before the experiment, after 7 days and at the end of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study.
Clinical signs:
No clinical signs were observed.
Body weight:
Body weight gain was normal during the study.
Gross pathology:
No pathological symptoms were observed, no macroscopic abnormalities were seen at ante-mortem and post-mortem examination.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was higher than 2000 mg/kg.
Executive summary:

The study was performed on a group of ten rats (5 male and 5 female). The test material was administered undiluted at a dose of 2000 mg/kg by dermal application under occlusive conditions for a exposure period of 24 hours. The animals were observed for 14 days thereafter. There were no deaths during the study. No clinical signs were detected during the experimental observation period. Body weight gain was considered normal for the species and strain of rats used in this study. No macroscopic abnormalities were seen at necropsy. The LD50 was higher than 2000 mg/kg. The results of the study indicate that the test material, 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C12 -13 -branched-alkyl) ester can be considered practically non toxic.