p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt

Endpoint summary

Description of key information

Based on a weight-of-evidence approach with three acute toxicity (oral, gavage) studies, the test item is not acutely toxic up to 5000 mg/kg bw in female rats. No adverse effects (clinical signs, symptoms, behaviour) were detected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1959

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

No methodoly description available

Qualifier:

no guideline available

Principles of method if other than guideline:

No description available

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

study cannot be used for classification

Conclusions:

The LD50 (oral) in mice was reported to be >10000 mg/kg bw. However as no methodolgy description is available this study is not considered reliable.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977-05-06 to 1997-05-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

WISKf

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
- Weight at study initiation: 180 - 204 g
- Fasting period before study: 16 h
- Housing: cage with saw dust
- Diet (e.g. ad libitum): Altromin 1324 ad libitum (2 h after application)
- Water (e.g. ad libitum): ad libitum

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: weekly (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: Faeces stained yellowish after application.

Gross pathology:

No effects found.

Other findings:

- Behaviour: no effects found

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not found to be acutely toxic by gavage to female Wistar rats (LD50 > 5000 mg/kg, limit test). No other symptoms or adverse effects were detected after application.

Executive summary:

The dye, present as an orange powder, was administered as a 25 % aqueous solution at a dose level of 5000 mg/kg body weight once by gavage to 10 female SPF Wistar rats, strain Hoe: WISKf(SPF 71) weighing 180 - 204 g (mean weight 193 g). The rats were not fed for 16 hours prior to application. Two hours after administration of the dye, the animals were given food again. The observation period after application was 14 days. During this period, in which the animals were weighed weekly, the animals were fed with ALTROMIN 1324 from Altromin GmbH in Lage/Lippe and tap water. Feed and water were offered ad libitum. The animals were kept in plastic cages on wood shavings. The experimental animals were killed under anaesthesia after the end of the follow-up period, dissected and macroscopically assessed.

Results:
No animal died when administered 5000 mg/kg body weight. After application, the animals showed normal behaviour. The body weight development during the follow-up period was regular. After administration of the dye, a yellow faecal colouration was observed.
The necropsy of the animals killed at the end of the experiment showed no macroscopic findings.
Due to the experimental design, an exact determination of the LD50 was not possible. However, the acute oral LD50 for female rats is certainly above 5000 mg/kg body weight.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1979-10-25 to 1979-11-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

WISKf

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 160 - 174 g
- Fasting period before study: 16 h
- Housing: cage with saw dust
- Diet (e.g. ad libitum): Altromin 1324 ad libitum (2 h after application)
- Water (e.g. ad libitum): ad libitum

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: weekly (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Gross pathology:

No effects found.

Other findings:

- Behaviour: no effects found

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not found to be acutely toxic by gavage to female Wistar rats (LD50 > 5000 mg/kg, limit test). No other symptoms or adverse effects were detected after application.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available