Sulfonation products of disodium sulfite with (esterification products of C9-11 (branched and linear) Alkyl Polyglycosides with maleic anhydride)

Endpoint summary

Description of key information

The acute oral toxicity test used for read-across was performed on a structural analogue . The study was performed according to OECD Short-term and Long-term toxicology groups and WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979. 
The acute dermal toxicity was investigated on the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" according to OECD guideline 402, EPA OPPTS 870.1200 (Acute Dermal Toxicity) and EC 440/2008, following GLP conditions.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

May 3 to 17, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not toxic. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. The alkylpolyglucoside has a carbon chain length range of C10-C14. They are both in the category of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the sub-categories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006

Principles of method if other than guideline:

The dose has been choosen in according with EEC directive 67/548.
References:
- OECD Short-term and Long-term toxicology groups.
- WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979

GLP compliance:

no

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: "Morini" - S.Polo d'Enza, Italy
- Weight at study initiation: 140-200 g
- Fasting period before study: pellet complete diet
- Housing: transparent polycarbonate cages of mm 425 x 266 x 180
- Water : filtered water from local network
- acclimation: at least 1 week before the start of the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.+/- 2 °C
- Humidity (%): 55 +/- 15 %
- Air changes (per hr): 25 times
- Photoperiod (hrs dark / hrs light): 12h/day

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days at frequent intervals during the first day and then daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no animals died

Clinical signs:

other: Slight piloerection in male rats no. 1, 3, 4, 5 and female rats no. 4, 5. This symptomatology is disappeared after 9 day from begining the study.

Gross pathology:

Slight mucosa enteritis in male rats n.1, 3

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was higher than 5000 mg/kg; no classification is required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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:

April 12 - 27, 2011

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

other: EC 440/2008

Principles of method if other than guideline:

Commission Regulation (EC) No 440/2008, L 142, Annex Part B of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

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:

Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female (non-pregnant and nulliparous).
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 weeks old; females: 11 weeks old
Body weight on the day of administration: males: 225 – 250 g; females: 210 – 233 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF).

Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1307)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 24/11/2010)
- Adequate acclimatisation period (at least five days)

Approximately 24.5 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.

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 held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure period the residual test item was removed by using aqua ad injectionem.

Duration of exposure:

24 hours

Doses:

2000 mg/kg
The active component of the test item is diluted in water (50 %); to assure the dose of 2000 mg/kg a correction factor of 2 was considered for preparation of the dressing with the test item, which has been consequently applied at a dose of 4000 mg/kg body weight.

No. of animals per sex per dose:

5

Details on study design:

All animals were observed for 14 days after dosing.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality

Clinical signs:

other: No treatment-related effects were observed

Gross pathology:

No treatment-related effects were observed

Other findings:

No erythema or oedema was observed. Desquamation was observed in 1 out of 5 female animals.
Eschar was observed in 5 out of 5 male and 4 out of 5 female animals. Scratches were observed in 3 out of 5 male animals.
All signs of irritation were reversible within the observation period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight (based on the active components) was associated with no mortality and neither signs of toxicity but minor signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg body weight (based on the active components).

Executive summary:

Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight (based on the active components) was associated with no mortality and neither signs of toxicity but minor signs of irritation.

The dermal LD50 was determined to be > 2000 mg/kg body weight (based on the active components).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not toxic (LD50 > 5000 mg/kg b.w.) .

The acute dermal toxicity test was performed in the year 2011, under GLP conditions and following the OECD guidelines. Under the conditions of the study, neither mortality nor signs of toxicity but minor signs of irritation were observed.

The dermal LD50 was determined to be > 2000 mg / kg body weight (based on the active components).

Justification for selection of acute toxicity – oral endpoint
The study refers to "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", a structurally related substance to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite". The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not toxic.

Justification for selection of acute toxicity – dermal endpoint
Study was performed with "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite". The study was carried out in GLP and according to an OECD standard method.

Justification for classification or non-classification

Basing on the results above reported and following the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" does not required classification for acute toxicity.

 

Oral Toxicity:

Classification : not required

Signal word : none

Hazard statement (Oral) : none

 

Dermal toxicity

Classification : Not required

Signal word : None

Hazard statement : None