Calcium 3,5,5-trimethylhexanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-05-31 to 1993-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study (OECD 402, EEC B3)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

in accordance with Directive 88/320EEC

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C9-13-neo-

EC Number:

273-114-3

EC Name:

Fatty acids, C9-13-neo-

Cas Number:

68938-07-8

Molecular formula:

C9H18O2 to C13H26O2

IUPAC Name:

Fatty acids, C9-13-neo-

Constituent 2

Reference substance name:

Fatty acids, C9-13-neo-

Cas Number:

68938-07-8

IUPAC Name:

Fatty acids, C9-13-neo-

Details on test material:

- Name of test material (as cited in study report): Versatic 913D, versatic 913 disstillate, C9-C13 neo acid mixture
- Substance type: carboxylic acid, mixture of neo-acids
- Physical state:clear pale yelow liquid
- Analytical purity: see below
- Composition of test material, percentage of components:
Versatic 5 content 0.8 % m/m
Versatic 6 content 5.8 % m/m
Versatic 7 content 6.2 % m/m
Versatic 9 content 70.0 % m/m
Versatic 10 content 0.9 % m/m
Versatic 11 content 0.2 % m/m
Versatic 13 content 6.9 % m/m
Greater than Versatic 13 3.2 % m/m
Versatic 9 isomers 43.9 % m/m
Water 0.14 % m/m
Acid value 346 mgKOH/g
Density (20°C) 0.922 kg/L
- Purity test date: 1993-05-18
- Lot/batch No.:Tank No. 1537; Ident 9450/9F09
- Stability under test conditions: stable
- Storage condition of test material: at ambient temperature in the dark

Test animals

Species:

rat

Strain:

other: CRL:CD.BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd.
- Age at study initiation: 5-6 weeks
- Fasting period before study: overnight
- Housing: individually in stainless steel cages
- Diet (ad libitum): LAD1 (Special Dites Services, Ltd.)
- Water (ad libitum): public water supply
- Acclimation period: at least 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light): fluorescent lighting; 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal, 6 x 8 cm
- % coverage: 100
- Type of wrap if used: waterproof adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm detergent solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not stated, mean dose 480 mg for males (mean weight 240 g) and 374 mg for females (mean weight 187 g)

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 times at the day of dosing, twice daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Statistics:

yes, but not stated in detail

Results and discussion

Preliminary study:

1500 mg/kg: no lethality in one male and one female animal

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no

Clinical signs:

other: hunched posture of most females

Gross pathology:

no macroscopic changes observed

Other findings:

- Other observations: yellow staining of the anogenital fur, yellow/brown dicolouration and erythema at the application site in all animals, flaking and wrinkled appearance of the test site in females. These effects had resolved by day 11

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the dermal LD50 in rats was greater than 2000 mg/kg.

Executive summary:

Five male and female rats were treated dermally with doses of 2000 mg/kg in a study according to guidelines OECD 402 and EEC B3. No mortality was observed within 14 days. Therefore the dermal LD50 in rats is > 2000 mg/kg (Sittingbourne Research Centre, 1994).