Potassium (E,E)-hexa-2,4-dienoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (GLP)

Justification for type of information:

Since the sorbate anion in the (eco-) toxicologically relevant moiety and its presence in dissociated or non-dissociated form is entirely determined by pH, extrapolation to potassium sorbate or vice versa is not considered to be restricted in any way.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987-02-24

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2000-08-02

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexa-2,4-dienoic acid

EC Number:

203-768-7

EC Name:

Hexa-2,4-dienoic acid

Cas Number:

110-44-1

Molecular formula:

C6H8O2

IUPAC Name:

hexa-2,4-dienoic acid

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 or test system 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 levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was osberved.

Clinical signs:

other: No signs of toxicity were observed.

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
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.