2-cyclododecylpropan-1-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-01-14 to 1993-02-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test according to OECD guideline 402 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HYDROXYAMBRAN

IUPAC Name:

HYDROXYAMBRAN

Test material form:

solid: crystalline

Details on test material:

Hydroxyambran
Test Material is a solid, but for the administration the test material was melted at 37 °C and applied as liquid.

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Species: rat
Strain: Bor: WISW (SPF Cpb)
Source: Firma Winkelmann, Versuchtierzucht, Gartenstr. 27, W-4799 Borchen
Date of receipt December 16, 1992
Acclimation period: at least 5 days
Animal selection: random
Animal identification: with colored markings; cage labelled with dosage, sex, date of study initiation, project no.
Weight range at
study initiation: m: 292 – 327 g; f: 201 – 214 g

Husbandry:
Housing: individual housing in cages (Macrolon type II)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 22 +/- 3 °C
Relative humidity: 30 – 70 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-R, Alleindiät
Form: Pellets
Water: Administration: ad libitum
System: drinking bottles
Quality: Drinking water as for human consumption
Quality control: half-yearly analyses and bacteriological tests

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

A single dermal application of the test article was performed. The substance was held in contact with the skin with a porous gauze dressing Elastoplast (Beiersdorf). The exposure period was 24 h. The test article was applied undiluted in a volume of 2.11 ml/kg. Prior to administration the test article was warmed in a water bath to 37 °C for 15 min.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Range finding (preliminary study): 2 female animals
Main test: 5 male and 5 female animals

Control animals:

not required

Results and discussion

Preliminary study:

There were no deaths in the preliminary study.

Effect levels

Sex:

male/female

Dose descriptor:

LD100

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the course of the main study.

Clinical signs:

No abnormal clinical signs were observed.

Body weight:

Weights gains were normal in all animals

Gross pathology:

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

Other findings:

Skin reactions:
No signs of erythema and oedema were observed apart from very slight or well-defined erythema in one female at day 1 and 2 p.a. Slight scale formation was observed in this animal at day 2 and 5 p.a.

Any other information on results incl. tables

Body weights:

Individual Values:

Animal No.	Sex	Day 0	Day 7	Day 14
1	m	301	306	321
2	m	327	364	389
3	m	299	307	327
4	m	321	334	352
5	m	292	296	314
6	w	201	201	212
7	w	214	212	220
8	w	205	210	211
9	w	206	198	204
10	w	203	201	202

 

Mean Values:

Sex	n	Day 0	Day 7	Day 14
males	5	308	321	341
females	5	206	204	210

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD 50 dermal rats is > 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of Hydroxyambran was determined according to the OECD Test Guideline 402 in a limit test using 2000 mg/kg bw.

 

The LD 50 dermal rats of Hydroxyambran is > 2000 mg/kg bw.

At this dose died no animal.