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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
27 May - 09 Jun 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions. The analytical purity of the test substance was not specified; necropsy was not performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
necropsy not performed
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
necropsy not performed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): palmitate d'isostearyle
- Physical state: clear liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature in sterile bottle

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 220.7 - 243.6 g (males) and 199.0 - 216.0 g (females)
- Fasting period before study: animals were fasted for 24 hours prior to dosing
- Housing: animals were housed 5 per cage in polycarbonate cages (450mm x 300mm x 200mm), which had a type E wire floor and contained absorbent material
- Diet: feed A04 (U.A.R., Epinay Sur Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-75
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 May 1999 To: 9 Jun 1999

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
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: animals were observed for mortality and clinical signs immediately, 15 mins and 6 hours after administration, and daily thereafter (5 days per week); animals were weighed on Day 0, 7 and 14
- Necropsy of survivors performed: no

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: No mortality or clinical signs were observed at this dose level.
Mortality:
There was no mortality during the study period.
Clinical signs:
No clinical signs were observed during the 14-day study period.
Body weight:
No effect on body weight was noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified