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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a Guideline study. Study was conducted in accordance to GLP and OECD guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Propoxylated glycerol mw 300 (NLP) described as a colourless viscous liquid, purity not reported.
Batch Number: 0133759A
Purity: 99.98%, Contains 200 ppm antioxidant.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Manston, Kent, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 134-156g; females 132-150g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded on the day of dosing and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded, no tissues were retained.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Remarks on result:
other: No signs of systemic toxicity observed at 2000 mg/kg bw.
Mortality:
No animals died.
Clinical signs:
There were no signs of systemic toxicity. All rats gained in bodyweight over the observation period.
Gross pathology:
Unremarkable.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The rat oral LD50 for this glycerine/propylene oxide adduct mw 300 is >2000 mg/kg. No adverse effects were observed at this dose level.