Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (GLP)
Justification for type of information:
The extrapolation from sorbic acid to potassium sorbate or vice versa is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1987-02-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2000-08-02
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Sorbic acid
- Specification: following the purity criteria on food additives other than colours and sweeteners Directive 96/77/EC).
- Physical state: white, crystalline powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: males: 42 days; females: 54 days
- Weight at study initiation: males: 205-211 g; females: 189-197 g

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: sesame oil
Details on dermal exposure:
- Area covered: The shaved intact dorsal skin (5 × 6 cm - 1/10 of body surface).
- Total volume applied: 10 mL/kg bw
- Removal of test substance: after 24 hours
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Number of animals per group: 5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: clinical observations on initial day at 0, 5, 15, 30, 60 min and 3, 6 and 24 h after administration. Mortality observation at least once daily. Body weight observations on initial day, day 8 and day 15.
- Other examinations performed: development of erythema and oedema, macroscopic and microscopic examination
Statistics:
Statistical methods: not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was osberved.
Clinical signs:
No signs of toxicity were observed.
Body weight:
All rats gained weight relative to their day 1 body weights upon study termination.
Gross pathology:
All animals were without pathological findings.
Other findings:
No skin reactions observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male rats) > 2000 mg/kg bw
LD50 (female rats) > 2000 mg/kg bw