Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.