Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
Not specified in report.
Qualifier:
according to guideline
Guideline:
other: Method 83 in Commission Directive 84/449/EEC
Deviations:
no
Remarks:
Not specified in report.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
405-430-6
EC Name:
-
Cas Number:
65143-89-7
Molecular formula:
UVCB
IUPAC Name:
2-hexadecyl-4-(2-sulfophenoxy)benzene-1-sulfonic acid 2-hexadecyl-4-(4-sulfophenoxy)benzene-1-sulfonic acid 2-hexadecyl-5-(2-hexadecylphenoxy)benzene-1-sulfonic acid 3-hexadecyl-5-(3-hexadecyl-4-sulfophenoxy)benzene-1-sulfonic acid hexasodium hydride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test material: Dowfax 8390
Reference: Lot # 880225
Appearance: white powder
Purity: 91.6%
Source: The Dow Chemical Company

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Specification
Five male and five female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K. At the start of the study the males weighed 211 - 239g, and the females 205 - 222g, and were approximately ten to fourteen weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.

Husbandry
The animals were housed individually in solid-floor polypropylene cages during the 24-hour exposure period. For the remainder of the
study, the animals were housed in groups of five by sex in polypropylene grid-floor cages suspended over trays lined with absorbent
paper. Free access to mains drinking water and food (Rat and Mouse Expanded Diet. No. 1, Special Diet Services Limited, Witham, Essex,
U.K.) was allowed throughout the study.

The animal room was maintained at a temperature of 19 - 25C and relative humidity of 45 - 54%. The rate of air exchange was approximately
15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day before treatment the back and flanks of each animal were clipped free of hair using vetrinary clippers to expose a skin area of
approximately 5 cm x 4 cm. A group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg.

The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial. The test material was then applied
uniformly to an area of shorn skin (approximating to 10% of the total body surface area) which had previously been moistened with distilled water. A
piece o f aluminium foil measuring 7 cm x 4 cm was placed over the treatment area and occluded with a piece of self-adhesive bandage (HYPERTIE).
The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.

Shortly afterr dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the bandage and foil
were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual
test material. The aninals were returned to group housing for the rest of the study.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
On the day before treatment the back and flanks of each animal were clipped free of hair using vetrinary clippers to expose a skin area of
approximately 5 cm x 4 cm. A group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg.

The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial. The test material was then applied
uniformly to an area of shorn skin (approximating to 10% of the total body surface area) which had previously been moistened with distilled water. A
piece o f aluminium foil measuring 7 cm x 4 cm was placed over the treatment area and occluded with a piece of self-adhesive bandage (HYPERTIE).
The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.

Shortly afterr dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the bandage and foil
were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual
test material. The aninals were returned to group housing for the rest of the study.

Deaths and overt signs of toxicity were recorded 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.

At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an
external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity or skin irritation were noted during the study.
Body weight:
No toxicologically significant on bodyweight were noted during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, DOWFAX 8390-D, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No risk phrase is required according to EEC labelling regulations.
Executive summary:

The acute dermal toxicity of a powdered Dowfax 8390 sample was evaluated in rats. The study conformed to OECD Guideline Number 402 and Method 83 in Commission Directive 841449lEEC.

Five male and five female Sprague-Dawley rats were treated with a single, occluded, dermal application of the undiluted test material to the intact skin which was moistened with distilled water. The material was applied at a dose level of 2000 mg/kg body weight to an area of shorn skin which approximated 10% of the total body surface area. Twenty-four hours after application, the dressing and residual test material were removed. The rats were observed for signs of toxicity and death at 0.5, 1, 2 and 4 hours after dosing and subsequently at least once a day for 14 days. Body weights were recorded on the day of treatment and on days 7 and 14. The rats were examined for gross pathologic changes at the termination of the study.

Dermal application of the test material did not result in any deaths, signs of systemic toxicity or skin irritation. No significant effects on body weight were noted during the study and there were no treatment-related post mortem observations at the termination of the study.

The acute dermal median lethal dose (LD50) of DOWFAX 8390 was greater than 2000 mg/kg body weight in the Sprague-Dawley rat. This degree of dermal toxicity does not require classification or labelling according to the criteria of the Commission of the European Communities (Annex VI of Council Directive 671548lEEC).

Categories Display