Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
No guideline or experimental methodology stipulated in the report summary.
GLP compliance:
yes
Remarks:
study pre-dates GLP
Test type:
other: no data
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fructone
IUPAC Name:
Fructone

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further information on test animals and environmental conditions is reported.

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5.0 g/kg
No. of animals per sex per dose:
10 animals were used in the study.
Control animals:
not specified
Details on study design:
no data

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
not specified
Mortality:
None of the 10 animals tested died during the study.
Clinical signs:
other: Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip.
Gross pathology:
Eight survivors appeared normal at necropsy. Two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.
Other findings:
Skin irritation was observed on day 1.
Slight redness was observed in eight animals and moderate redness was observed in one animal; the other treated animal was observed to have no redness.
Slight edema was noted on 4 animals, moderate edema on 2 animals and no edema on the remaining 4 animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.
Executive summary:

The acute dermal toxicity of the test material was investigated with 10 rabbits; each was dermally administered 5.0 g/kg test material, in a limit test. None of the animals tested died during the study. Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip. Slight to moderate redness and edema was noted in some animals during the observations for skin irritatation on day 1. At gross necropsy eight survivors appeared normal, two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.

The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.