Potassium 3-sulphonatopropyl acrylate

Endpoint summary

Description of key information

Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (limit test)

Dermal (OECD 403), rat: LD50 > 2000 mg/kg bw (limit test)

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:

01 - 20 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD(SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 212-216 g (females) and 207-261 (males)
- Fasting period before study: overnight, until 3-4 hours after dosing
- Housing: animals were housed in groups of 3 by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded diet No.1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a limit test with 2000 mg/kg bw as the starting dose is recommended, according to OECD 423 - Acute toxic class method, if information on the test substance suggests mortality is unlikely at the highest dose level.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs 1/2, 1, 2 and 4 hours after dosing and then once daily for 14 days. The body weight was recorded prior to dosing, and 7 and 14 days after dosing.
- Necropsy of survivors performed: yes, the animals were subjected to gross pathological examination

In the first step 3 females were dosed, and as there was no mortality, in the second step 3 males were dosed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and gross pathological examination revealed no substance-related findings.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, of Regulation (EC) No 1907/2006.

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:

06 - 20 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

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)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD(SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 206-226 g (females) and 191-232 (males). One male weighed less than the 200 g specified in the Standard Test Method, but this was not considered to have affected the integrity of the study.
- Fasting period before study: no
- Housing: animals were housed individually during the exposure period and in groups of 5 by sex for the remainder of the study; in suspended polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse SQC Expanded diet No.1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

the test substance was moistened with distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: a shorn area on the back and flank of the rats
- % coverage: 10
- Type of wrap if used: self-adhesive semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was cleaned with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/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: animals were observed for mortality and clinical signs 1/2, 1, 2 and 4 hours after dosing and then once daily for 14 days. The body weight was recorded prior to dosing, and 7 and 14 days after dosing. The test site was observed for primary irritation (erythema and edema, according to the Draize scoring system) once daily for 14 days.
- Necropsy of survivors performed: yes, the animals were subjected to gross pathological examination

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and gross pathological examination revealed no substance-related findings.

Other findings:

There were no signs of dermal irritation; all erythema and edema scores were 0.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

In the acute oral toxicity study (according to OECD 423), the limit dose of 2000 mg/kg bw sulfopropyl acrylate (SPA) was administered to male and female rats by gavage (Driscoll, 2001). There were no mortality, no clinical signs and no effects on body weight during the 14 day observation period. The necropsy and gross pathological examination did not reveal any treatment-related effects. According to the acute toxic class method described in the OECD guideline 423, if there is no mortality following administration of 2000 mg/kg bw, the LD50 cut-off limit is 5000 mg/kg bw. Therefore, the LD50 is considered to be 5000 mg/kg bw for male and female rats.

The acute dermal toxicity of SPA was assessed in a limit test performed in rats, according to OECD 403 (Driscoll, 2001). A single dose of 2000 mg/kg bw of the moistened test substance was applied to the shaved skin of rats under semiocclusive conditions and left for 24 hours. There were no mortality, no clinical signs and no effects on body weight during the 14 day observation period. The necropsy and gross pathological examination did not show any treatment-related effects, and there were no signs of irritation at any time point on the treated skin sites. The LD50 is considered to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.