Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 November 1987 to 25 November 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity".
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
No further details specified in the study report.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female Sprague-Dawley CFY strain rats were supplied by Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire. At the start of the study the males weighed 232 - 245g, and the females 241 - 258g, and were approximately ten to fourteen weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a cage card.
The animals were housed in solid-floor polypropylene cages with sawdust bedding and allowed free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) throughout the study.
The animal room was maintained at a temperature of 19 – 22 °C and relative humidity of 45 - 65%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately twenty-four hours prior to the commencement of the test the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 6 cm x 12 cm.
The appropriate amount of the test material, as received, pre-weighed into a glass vial, was applied uniformly to an area of shorn skin approximating to 10% of the total body surface area which had previously been moistened with arachis oil B.P. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a double layer of elastic adhesive bandage (ELASTOPLAST) wrapped around the trunk of the rat. The bandage was tightened sufficiently to prevent the animal wriggling free.
The rats were individually caged for the 24-hour exposure period to prevent mutual interference with the dressing. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with moist cotton wool to remove any residual test material. The animals were then caged in groups of five by sex.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males/5 females)
Control animals:
no
Details on study design:
All animals were observed for overt signs of toxicity and mortality 1 and 4 hours after dosing and subsequently at least once daily for fourteen days.
Individual bodyweights were recorded on the day of treatment (day 0) and on days seven and fourteen.
All animals were subjected to a gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
Using the mortality data, an assessment of the acute dermal median lethal dose (LD50) of the test material was made. Clinical observations, bodyweight records and necropsy data were examined for any adverse, but non-lethal effects resulting from treatment.

Results and discussion

Preliminary study:
Not specified in the study report.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No signs of systemic toxicity or skin irritation were noted during the study period.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study period.
Other findings:
All application sites were stained blue by the test material orr removal of the dressings and up to five to six days after treatment.

Any other information on results incl. tables

The mortality data are summarised as follows:

DOSE LEVEL

mg/kg

SEX

DEATHS ON DAY:

TOTAL DEATHS

0

1

2

3

4

5

6

7

8-14

2000

MALE

0

0

0

0

0

0

0

0

0

0/10

FEMALE

0

0

0

0

0

0

0

0

0

 

INDIVIDUAL CLINICAL OBSERVATIONS

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

HOURS AFTER DOSING

DAYS AFTER DOSING

1

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000

1-0 MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

1-1 MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

1-2 MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

1-3 MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

1-4 MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

2-0 FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

0

2-1 FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

0

2-2 FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

0

2-3 FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

0

2-4 FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

0

St = site of application stained blue by test material   0 = no systemic toxicity detected

 

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT INCREASES

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

BODYWEIGHT (g) AT DAY

INCREMENT (g) DURING WEEK

0

7

14

1

2

2000

1-0

MALE

232

281

345

49

64

1-1

MALE

243

308

392

65

84

1-2

MALE

245

267

362

22

95

1-3

MALE

234

280

345

46

65

1-4

MALE

237

288

349

51

61

2-0

FEMALE

250

281

302

31

21

2-1

FEMALE

241

250

278

9

28

2-2

FEMALE

252

278

298

26

20

2-3

FEMALE

244

259

272

15

13

2-4

FEMALE

258

274

292

16

18

 

INDIVIDUAL NECROPSY FINDINGS

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

MACROSCOPIC OBSERVATIONS

2000

1-0

MALE

Killed day 14

No abnormalities detected

1-1

MALE

Killed day 14

No abnormalities detected

1-2

MALE

Killed day 14

No abnormalities detected

1-3

MALE

Killed day 14

No abnormalities detected

1-4

MALE

Killed day 14

No abnormalities detected

2-0

FEMALE

Killed day 14

No abnormalities detected

2-1

FEMALE

Killed day 14

No abnormalities detected

2-2

FEMALE

Killed day 14

No abnormalities detected

2-3

FEMALE

Killed day 14

No abnormalities detected

2-4

FEMALE

Killed day 14

No abnormalities detected

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test material, Dispersionsblau F 60 768, to the rat was found to be greater than 2000 mg/kg bodyweight.
The substance is not classifiable according to CLP criteria.
Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CFY strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity".

 

A group of ten animals (five males and five females), was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin, at a dose level of 2000 mg/kg bodyweight.

 

There were no deaths. There were no signs of systemic toxicity or skin irritation over the study period. All application sites were stained blue by the test material.

 

All animals showed expected gains in bodyweight over the study period.

 

No abnormalities were noted at necropsy of animals killed at the end of the study period.

 

The acute dermal median lethal dose (LD50) of the test material, DISPERSIONSBLAU F-60 768, to the rat was found to be greater than 2000 mg/kg bodyweight.

The substance is not classified according to CLP criteria.