Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Remarks:

Not specified in report.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Method B1 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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

405-430-6

EC Name:

-

Cas Number:

65143-89-7

Molecular formula:

UVCB

IUPAC Name:

Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt

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
Male and female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K. At the start of the main study the males weighed 142 - 155g, and the females 132 - 142g, and were approximately five to eight 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 in groups of up to five by sex in solid - floor polypropylene cages with sawdust bedding. With the exception of an
overnight fast immediately before dosing and for approximately two hours after dosing, 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 16 - 22°C and relative humidity of 30 - 56%. On occasions the temperature was below the lower limit specified in the protocol (19°C). This did not affect the purpose or integrity of the study. 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

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water. All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. Dose volume 10 ml/kg

Doses:

5000 mg/kg (limit dose), concentration 500 mg/ml

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each
animal was calculated according to its fasted bodyweight at the time of dosing.

Deaths and overt signs of toxicity were recorded 30 minutes, 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:

> 5 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: An isolated incident of hunched posture was confined to one male four hours after dosing. No other signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Preliminary study- The male treated with 5000 mg/kg and the female treated with 3000 mg/kg were found dead one day after treatment. Isolated incidents of systemic toxicity noted were hunched posture and lethargy. Based on this information, a dose level of 5000 mg/kg body weight was initially selected for the main study.

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 oral median lethal dose (LD50) of the test material, DOWFAX 8390, in the Sprague-Dawley strain rat was found to be greater than 5000
mg/kg bodyweight. No symbol and risk phrase are required.

Executive summary:

The acute oral toxicity of a powdered Dowfax 8390 sample was evaluated in rats. The study conformed to OECD Guideline Number 401 and Method B1 in Commission Directive 84/449/EEC.

Subsequent to a range-finding study, five male and five female Sprague-Dawley rats were given a single gavage dose of the test material as a solution in distilled water at a dose level of 5000 mg/kg body weight. Animals were observed at 0.5, 1, 2 and 4 hours after dosing and then once daily for 14 days. Individual body weights were recorded on the day of treatment and on days 7 and 14. Animals were examined for gross pathological changes at the termination of the study.

Oral treatment with the test material did not result in any deaths. One male rat had a hunched posture at four hours after dosing. No other clinical signs were noted. There were no significant effects on body weights during the study and there were no treatment-related post-mortem observations at the termination of the study.

The acute, oral median lethal dose (LD50) of DOWFAX 8390 Surfactant was greater than 5000 mg/kg body weight in the Sprague-Dawley rat.

This degree of oral toxicity does not require classification or labelling according to the criteria of the Commission of the European Communities (Annex VI of Council Directive 67/548/EEC).