Potassium 4-acetoacetylaminobenzenesulphonate

Endpoint summary

Description of key information

ACUTE ORAL TOXICITY:
A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute oral toxicity). The acute oral median lethal dose (LD50) of the test item in the rat was found to be > 5000 mg/kg.
ACUTE DERMAL TOXICITY:
A study was carried out according to EU Method B.3 and OECD Guideline 402 (Acute dermal toxicity). The acute dermal median lethal dose (LD50) of the test item in the rat was found to be > 2000 mg/kg.

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:

March - April 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline study, non-GLP

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

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: Bantin and Kingman, Grimston, Aldbrough, Nr. Hull, HUll 4QE
- Age at study initiation: no data
- Weight at study initiation: 125-225 g
- Fasting period before study: overnight before treatment
- Housing: gang housing in groups of 2 or 5 by sex as appropriate in grid floor polypropylene boxes
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Expanded Diet, BP Nutrition (U.K.) Ltd., Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 19 - 25°C
- Photoperiod (hrs dark / hrs light): natural lighting conditions

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

- Pre-test: 10, 50, 500, 5'000 and 15'000 mg/kg
- Main study: 5000 mg/kg

No. of animals per sex per dose:

- Pre-test: 1 male / 1 female per dose group
- Main study: 5 males / 5 females

Control animals:

no

Preliminary study:

100% mortality was observed at 15'000 mg/kg in the pre-test only.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed in main study.

Clinical signs:

other: None reported.

Gross pathology:

None reported.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 on Wistar rats was found to be > 5000 m/kg (males/females).

Executive summary:

The acute oral toxicity on Wistar rats was assessed in a study equivalent or similar to OECD testing method no. 401. A range-finding test with reduced number of animals and dose groups of 10-15'000 mg/kg was performed, followed by the main study with a limit dose of 5000 mg/kg bw.

Neither mortality nor signs of toxicity were observed in the main study. In conclusion, the acute oral LD50 on Wistar rats was determined to be > 5000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

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:

supporting study

Study period:

March 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other 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

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Nossan S.r.I., Correzzana (MI), Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g
- Housing: individually in polycarbonate cages
- Diet (e.g. ad libitum): commercially available laboratory rodent diet (Altromin MT, A. Rieper S.p.A., Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): artificial cycle of 12 hours light and 12 hours dark each day

Type of coverage:

semiocclusive

Vehicle:

water

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following dosing.

Clinical signs:

other: No clinical signs were observed, with the exception of an abrasion, which became a scab, observed in a single female animal on Days 2, 3 and 4. This sign was not considered to be related to treatment with the test substance.

Other findings:

No abnormalities were found on necropsy of animals on termination of the study.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermall LD50 on Sprague-Dawley rats was found to be > 2000 m/kg (males/females).

Executive summary:

The acute dermal toxicity on Sprague-Dawley rats was assessed in a study following OECD testing method no. 403. A limit test with a dose of 5000 mg/kg bw was performed. Neither mortality nor signs of toxicity were observed in the main study. In conclusion, the acute oral LD50 on rats was determined to be > 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Source: GLP-reports

Justification for selection of acute toxicity – oral endpoint
non-GLP study following OECD-guideline; Klimisch 2

Justification for selection of acute toxicity – dermal endpoint
GLP study following OECD-guideline; Klimisch 1

Justification for classification or non-classification

Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).