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Diss Factsheets

Administrative data

Description of key information

Key studies for oral and dermal acute toxicity were performed, demonstrating LD50 >2000 mg/kg bw after both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulphosuccinates due to their substance properties and the risk management measures that are already implemented.

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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conduced non-GLP, however quality inspections were performed and it was conducted according to valid test methods. Therefore it is considered relevant, adequate and reliable for classification.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
however quality inspections were performed demonstrating validity of the study
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
- Source: Winkelmann, Borchen
- Age at study initiation: Young, adult
- Weight at study initiation: Not provided
- Fasting period before study: 16 hours (and 3 hours after application)
- Housing: Macrolon 3 cages, 5 animals per cage,softwood pellets (ARWI-Center, Essen)
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324, Fa. Altromin GmbH, 4937 Lage (Germany), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):ca. 20-25 °C
- Humidity (%): 45-60%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-05-04 To: 1989-05-19
Route of administration:
oral: gavage
Vehicle:
other: CMC (carboxymethyl cellulose) 1% and Cremophor 0.5%
Details on oral exposure:
VEHICLE = 1% Carboxymethylcellulose + 0.5% Cremophor
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL.kg b.w.

Doses:
10 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation at day of application several times, thereafter 2 times daily; weighing 1 day before application, fasted at day of application, at 48 hours, 7 days and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality.
Clinical signs:
other: No findings.
Gross pathology:
No findings.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was > 2000 mg/kg bw for male and female rats.
Executive summary:

The acute oral toxicity of the test item containing 40% active ingredient was tested in young Wistar rats. The test item was administered by single oral gavage as a 20% solution in 1% Carboxymethylcellulose – 0.5% Cremophor as solvent and an application volume of 10 mL/kg bw. Five rats were used per sex. The LD50 was > 2000 mg act. ingr./kg bw for male and female rats. There were no clinical obervations or changes in body weight or macroscopic pathology.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
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:
2012-2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test was conducted according to GLP and valid test methods, therefore it is considered relevant, adaquate and reliable for classification.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CD / Crl:CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories GmbH, Sandhofer Weg 7, 97633 Sulzfeld,Germany
- Age at dosing: Approx. 8 weeks
- Weight at dosing: Males: 252 - 272 g; Females: 235 – 249 g
- Fasting period before study: Approx. 16 hours before administration; only tap water will be then available ad libitum.
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet (e.g. ad libitum): ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) ad libitum. Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Water (e.g. ad libitum): Drinking water in bottles was offered ad libitum.
- Acclimation period: 7 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C (maximum range)
- Humidity (%): 55% ± 15% (maximum range).
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: November 19, 2012 To: December 11, 2012
Type of coverage:
occlusive
Vehicle:
physiological saline
Remarks:
aqua ad iniectabilia
Details on dermal exposure:
TEST SITE
- Area of exposure: The intact dorsal skin of the animals was shaved free of hair with a shaver without causing injury approximately 24 hours before application. The site was situated on the animals back between the fore and hind extremities and had an area of at least 5 cm x 6 cm.
- % coverage: approx. 10% (1/10 of body surface)
- Type of wrap if used: The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster on the application site for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes. At the end of the exposure period, possible residual test item was removed where practicable using water or some other appropriate method of cleaning the skin.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg active ingredient/kg bw
- For solids, paste formed: yes. 7011 mg Butanedioic acid, sulfo-, mono (C16-18 and C18-unsatd. alkyl)esters, ammonium sodium salts was moistened with 3505 mg aqua ad iniectabilia. Thereof 3120 mg/kg bw was applied. A correction factor of 1.04 was used.


Duration of exposure:
24 hours
Doses:
2000 mg act. ingr./kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days.
During the follow-up period (2 weeks) changes in skin and fur, eyes and mucous membranes, and the respiratory, circulatory, autonomic and central ner¬vous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma..
Observations on deaths were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. No histopathology was carried out as no macroscopical findings were noted at necropsy.
- Other examinations performed: clinical signs, body weight, other: The skin was observed for the development of erythema and oedema .


Statistics:
The LD50 could not be calculated as no animal died prematurely.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
None of the animals died prematurely.
Clinical signs:
other: No signs of toxicity were observed. A very slight erythema (barely perceptible) on the application site was observed in 5 of 5 male and 5 of 5 female animals on test days 2, 3 and 4.
Gross pathology:
No macroscopic findings were observed at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions the test item containing 95.8% active ingredient requires no labeling (as LD50 > 2000 mg/kg bw).
Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test item is not classified for acute dermal toxicity.
Executive summary:

Test item containing 95.8% active ingredient was tested in a acute dermal toxicity study. A single dermal administration of 2000 mg act.ingr. /kg bw to 5 male and 5 female CD rats for 24 hours under an occlusive patch,revealed no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in 5 of 5 male and 5 of 5 female animals on test days 2, 3 and 4. All animals gained the expected body weight throughout the whole experimental period.

According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions the test item containing 95.8% active ingredient requires no labeling (as LD50 > 2000 mg/kg bw).

Also, according to the EC Regulation 1272/2008 and subsequent regulations, the test item is not classified for acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality

Additional information

Acute oral toxicity

In a key acute oral toxicity study with registered substance, the test item containing 40% active ingredient was tested in young Wistar rats by single gavage as a 20% solution in 1% Carboxymethylcellulose – 0.5% Cremophor as solvent and an application volume of 10 mL/kg bw (Potokar, 1989). Five rats were used per sex. The LD50 was >2000 mg act.ingr. /kg bw for male and female rats. There were no clinical obervations or changes in body weight or macroscopic pathology.

In conclusion, there is no hazard for acute oral toxicity.

Acute dermal toxicity

In a key acute dermal toxicity study with registered substance, the test item containing 95.8% active ingredient was tested in CD rats under occlusion for 24 hours with 2000 mg act.ingr./kg bw (Haferkorn, 2013). There were no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in 5 of 5 male and 5 of 5 female animals on test days 2, 3 and 4. All animals gained the expected body weight throughout the whole experimental period and did not elicit gross pathological findings. LD50 was > 2000 mg/kg bw.

In conclusion, there is no hazard for acute oral toxicity.

Acute inhalation toxicity

Inhalation is very unlikely due to large particle size, low vapour pressure and high hydrophilic properties of the substance. Based on these and other physicochemical properties, the inhalation route is not appropriate; the oral and dermal route of administration are therefore applied as first and second relevant routes (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity study is waived.

Conclusion

- There is no hazard for acute oral and dermal toxicity, based on LD50values >2000 mg/kg bw.

- Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), classification is not obligatory for oral and dermal acute toxicity.