Reaction mass of sodium 4-hydroxybenzenesulfonate and disodium 4-hydroxybenzene-1,3-disulfonate and sodium sulfate

Endpoint summary

Description of key information

LD50 oral > 2000 mg/kg bw

LD50 dermal > 2000 mg/kg bw

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study under GLP condition

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Vehicle:

other: distilled water

Doses:

0, 2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

[Mortality / Clinical signs]
No deaths occurred during the study. 

    
    

Diarrhea was observed for both sexes in the 2000 mg/kg bw groups.

[Body weight]
There were no treatment-related changes in body weight in either sex.

[Necropsy]
No macroscopic abnormalities were observed at autopsy in either sex.

LD50 in male and female rats were greater than 2000 mg/kg bw.

Interpretation of results:

practically nontoxic

Remarks:

Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The datatbase contains good studies on sodium sulphate, two studies on the acid form of hydroxybenzenesuphonate of very low reliability, several studies on acid and salt form of analogues substances. All studies are consistent and reveal a low toxicity for all components.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Clinical signs:

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:

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

Adequacy of study:

weight of evidence

Study period:

April 7-21, 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline test; GLP compliance, full documentation

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products, Michigan
- Age at study initiation: 5 months
- Weight at study initiation: nakes 2944-3091g and females 2915-3155g
- Fasting period before study: no data
- Housing: individually in hanging stainless steel wire mesh cages
- Diet: up to 125 g/day
- Water: ad libitum
- Acclimation period: minimum of 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no values reported
- Humidity (%): controlled but no values reported
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- other: The animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guuide for the Care and Use of Laboratory Animals".

IN-LIFE DATES: From: April 7 To: April 21

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

On the day prior to dosing, the hair was removed from the back of each rabbit with an electric clipper. The skin was left intact. The test material was applied once, as received, at a dose of 2000 mg/kg then spread evenly to cover 100% of the test site which was approximately 10% of the body surface. The test site was covered with a 1 x 1 inch gauze pad, wrapped with a gauze bandage, overwrapped with plastic wrap and then sealed with elastoplast tape. A collar was placed on each animal. The test site was washed 24 hours later with water and towel dried.

Duration of exposure:

24 hours

Doses:

2000 mg/Kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1,2 and 4 hours on day one then twice daily for the next 13 days. weighing prior to dosing, on day 8 and at study termination.
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

none

Clinical signs:

other: 4 of the 10 animals displayed no visible abnormal signs. Erythema was noted on day 3 in six animals with desquamation additionally obsserved on day 9 in one animal.

Gross pathology:

No visible abnormalities in 6 of the 10 animals. The remaining 4 displayed focal or multifocal red discoloration of the treated skin with one animal additionally displaying desquamation of the same site.

Interpretation of results:

practically nontoxic

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The dermal LD50 is > 2000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The database is constituted by consistent tests whith different sample, different date and methods, therefore in the whole the quality is good

Additional information

Acute Oral toxicity

The database contains good studies on sodium sulphate, two studies on the acid form of hydroxybenzenesuphonate of very low reliability, several studies on acid and salt form of analogues substances. All studies are consistent and reveal a low toxicity for all components. The studies with the acid form reveal some effects due to the corrosive nature of the substance and not to the intrinsic systematic acute toxicity, therefore the results are taken into account just as indicative values.

Acute inhalatory toxicity

No specific and reliable studies are available. A waiving justification is reported. Some indication of very low toxicity is given by literature studies with low reliability.

Dermal toxicity

There are acute dermal toxicity studies for closely related hyrotropes, salt form of the sulphonic acids. The LD50 for the salts is >2000 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint

The study is the only GLP study and the better reported

Justification for classification or non-classification

No basis for acute toxicity classification is found.