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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
30 Aug - 13 Sep 1983
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient for assessment due to reduced animal number. Only 2 male and 2 female animals were used, details on test substance not documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only two male and two female animals used, details on test substance not documented
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with pentaerythritol
EC Number:
285-547-5
EC Name:
Fatty acids, C16-18, esters with pentaerythritol
Cas Number:
85116-93-4
IUPAC Name:
85116-93-4

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: > 6 weeks
- Weight at study initiation: males: 282.5 g; females: 166.0 g
- Fasting period before study: 15 h
- Housing: Makrolon Type III cages
- Diet: Altromin-Haltungsdiät 1324, ad libitum
- Water: tap water, ad libitum
- Acclimation period: > 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 1.62 mL - 2.95 mL depending on body weight


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Frequency of observations and weighing: evaluation of mortality: twice daily; weighing on Days 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 d
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No significant signs of toxicity except for transient rough fur and reduced activity direct after dosing were observed.
Gross pathology:
No macroscopic findings were found at necropsy.

Applicant's summary and conclusion

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