Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]

Endpoint summary

Description of key information

Three oral and one dermal acute toxicity studies are available for the REACH-registered substance. This acute toxicity dataset is supplemented with the publically available secondary reference data on the REACH-registered substance and key information on the ADPODS category members (refer to full read-across ADPODS category justification document). No acute inhalation data are available for any of the ADPODS category members; however, as these have low vapor pressures, no inhalation exposures are expected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Three female Fischer 344 rats received the test material, as a 20% aqueous solution, by single dose oral gavage, at dose levels of 1500 or 2000 mg/kg.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Fischer 344

Sex:

female

Details on test animals or test system and environmental conditions:

No additional data

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Rats received the test material, as a 20% aqueous solution, by single dose oral gavage.

Doses:

1500 and 2000 mg/kg

No. of animals per sex per dose:

3 females/dose

Control animals:

no

Details on study design:

Three female Fischer 344 rats received the test material, as a 20% aqueous solution, by single dose oral gavage, at dose levels of 1500 or 2000 mg/kg. In-life observations and body weights were recorded over a 2-week observation period.

Statistics:

None

Preliminary study:

No data

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 500 - < 2 000 mg/kg bw

Mortality:

No rats died at 1500 mg/kg and 2 out of 3 died at 2000 mg/kg.

Clinical signs:

other: In-life signs of toxicity observed on both dose groups included diarrhea. Lethargy, palpebral closure, and facial soiling (reddish color) were observed in the high dose animals only.

Gross pathology:

No data

Other findings:

None

None

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute oral LD50 for female rats was between 1500 and 2000 mg/kg.

Executive summary:

The test material, XU-40340.00 DOWFAX 3B2, powder form, was submitted by the Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company, Midland, MI. The material is of interest for use in the agriculture, cleaning, and textile industries. Standard acute toxicologic tests were conducted and included the acute oral toxicity, skin irritation, and eye irritation studies. The acute, oral LD50 for female Fischer 344 rats was between 1500 and 2000 mg/kg. Therefore, the acute oral toxicity of the test material was categorized as low.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 500 mg/kg bw

Quality of whole database:

acceptable

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

A single application of 2000 mg/kg of neat Dowfax 3B2 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Observations and body weights were recorded over a 2-week period.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

A single application of 2000 mg/kg of neat Dowfax 3B2 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 male rabbits

Control animals:

no

Details on study design:

A single application of 2000 mg/kg of neat Dowfax 3B2 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Observations and body weights were recorded over a 2-week period.

Statistics:

None

Preliminary study:

No data

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Erythema, edema and bums were observed, at the application site, immediately after removing the wrap. These observations were observed through test day four. By test day eight, both animals were observed with scaling, which persisted through the end of th

Gross pathology:

None

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: other: EU GHS

Conclusions:

The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.

Executive summary:

A sample of Dowfax 3B2 solution surfactant was submitted by Specialty Chemicals, The Dow Chemical Company, Midland. MI for evaluation of acute oral and dermal toxicity and skin and eye irritation. This compound is a potential ingredient in cleaning solutions.

A single application of 2000 mg/kg of neat Dowfax 3B2 was applied to the clipped tnmks of two male New Zealand White rabbits under an impervious, occlusive bandage Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. These observations were observed through test day four. By test day eight, both animals were observed with scaling, which persisted through the end of the study. Both animals survived the test period at the 2000 mg/kg dose level. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

acceptable

Additional information

In the key studies conducted with the REACH-registered substance, the acute oral and dermal toxicity were low, with an oral LD50 value of 1500 - 2000 mg/kg, and dermal LD50 value >2000 mg/kg (for the latter study, no deaths were observed). This is also true for the other ADPODS substances relevant for read across, indicating that this particular chemistry has a low order of acute toxicity via the oral and dermal routes.

No data are available for inhalation toxicity. However, this is unlikely to be a relevant route for human exposure due to the low vapor pressure and limited possibility for generating a large concentration of aerosol in normal handling conditions.

Justification for selection of acute toxicity – oral endpoint
acceptable limit dose study for the REACH-registered substance

Justification for selection of acute toxicity – dermal endpoint
acceptable limit dose study for the REACH-registered substance

Justification for classification or non-classification

Acute oral category 4 is required for Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate] according to CLP GHS. No dermal classification is required for the registered substance.