Disodium oxybis[methylbenzenesulphonate]

Endpoint summary

Description of key information

The acute toxicity of ditolylether disulfonic acid disodium salt, isomer mixture was tested using the oral and the dermal route yielding an LD50 >2000 mg/kg bw for both application routes. In none of the studies amanimals died or displayed signs of intoxication.  Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: step 1/animals no.1-3: 177-181 g, step 2/animals no 4-6: 178-183 g
- Fasting period before study: 16-19 hours
- Housing: in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: sterile water

Details on oral exposure:

The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.

Doses:

The starting dose was selected to be 2000 mg/kg bw. ( step 1 and step 2).
As no animal died no further testing is required.

No. of animals per sex per dose:

3 females in each step

Control animals:

no

Details on study design:

The test item was administered at a single dose by gavage using a feeding tube to 3 female rats in each step.
The test item was administered at a dose volume of 10 mg/ kg bw.
All animals were observed for 14 days after dosing for general climical signs, morbidity and mortality.
All animals were weighed on day 1 prior to dosing and on days 8 and 12.
A careful examination was made severla times on the day of dosing and thereafter once daily.

Statistics:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No compound - related mortality was recorded for any animal of step 1 and step 2.

Clinical signs:

other: female rat 1-6: No signs of toxicity were observed during the whole observation period.

Gross pathology:

At necropsy, some macroscopic changes (female 4 and 5: red spots on the lungs) were observed. These findings are not considered to be test item related.
No specific gross pathological changes were reported.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

Two groups, each of three female Wistar rats, are treated with ditolylether disulfonic acid disodium salt, isomer mixture by oral gavage administration at a dosage of 2000 mg/kg bw (OECD TG 423 and GLP). All animals were observed for 14 days post dosing. No mortality occurred and no clinical signs of intoxication were noted. Body weight gain was within the normal range. At necropsy, no treatment related macroscopic findings were observed in any animal of any step. Thus, the LD50 is > 2000 mg/kg bw.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and has Klimisch score 1.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 9 weeks, females 14 weeks
- Weight at study initiation: males 222-246 g, females 211-224 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

other: the opposite site to the treatment area

Details on study design:

The test item was applied at a single dose, uniformly over an area which was approximately 10 % of the total body surface.
The test item was moistened with water to ensure good skin contact and was held in place by semi-occlusive dressing for 24 hours.
At the end of the exposure period (24 hours) the residual test item was removed using tap water.
Animals were observed for 14 days for clinical signs and mortality. Necropsy was performed at the end of the study.

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no rat died, no signs of acute dermal toxiciy, no significant signs of dermal irritation

Mortality:

no rat died

Clinical signs:

other: no clinical signs of systemic toxicity: no significant signs of irritation

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Other findings:

No erythema or oedema was observed. Eschar was observed in 3 or 5 male and 4 of 5 female animals. These signs of irritation were reversible within the observation period in all animals with exception of one female rat.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

5 male and 5 female rats were dermally treated with moistened 2000 mg/kg bw ditolylether disulfonic acid disodium salt, isomer mixture for 24 hours. (OECD TG 402, limit test). The test item was held in place by semi-occlusive dressing.

Under the condition of this study single dermal application of ditolylether disulfonic acid disodium salt, isomer mixture to rats was associated with no mortality and neither signs of toxicity nor significant signs of irritation.

The dermal LD50 was determined to be > 2000 mg/kg bw.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and has Klimisch score 1.

Additional information

Acute oral toxicity

Two groups, each of three female Wistar rats, are treated with ditolylether disulfonic acid disodium salt, isomer mixture by oral gavage administration at a dosage of 2000 mg/kg bw (OECD TG 423). All animals were observed for 14 days post dosing. No mortality occurred and no clinical signs of intoxication were noted. Body weight gain was within the normal range. At necropsy, no treatment related macroscopic findings were observed in any animal of any step. Thus, the LD50 is > 2000 mg/kg bw.

 

Acute inhalation toxicity

In addition to the acute oral study there is another acute study available using dermal exposure route. There is no need to perform an acute inhalation toxicity study because the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.

 

Acute dermal toxicity

5 male and 5 female rats were dermally treated with moistened 2000 mg/kg bw ditolylether disulfonic acid disodium salt, isomer mixture for 24 hours (OECD TG 402, limit test). The test item was held in place by semi-occlusive dressing.

Under the condition of this study single dermal application of ditolylether disulfonic acid disodium salt, isomer mixture to rats was associated with no mortality and neither signs of toxicity nor significant signs of irritation.

The dermal LD50 was determined to be > 2000 mg/kg bw.

 

Overall conclusion

There are two acute toxicity studies with ditolylether disulfonic acid disodium salt, isomer mixture available using different application routes. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled. The results of these studies show that ditolyether disulfonic acid disodium salt, isomer mixture is practically non-toxic. These studies are of high quality (Klimisch score = 1) and therefore, there is no reason to believe that these results would not be applicable to humans.

 

Justification for selection of acute toxicity – oral endpoint
only one study available

Justification for selection of acute toxicity – inhalation endpoint
In addition to the acute oral study there is another acute study available using dermal exposure route. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled.

Justification for selection of acute toxicity – dermal endpoint
only one study is available

Justification for classification or non-classification

Based on the available data no classification and labelling is required