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Administrative data

Description of key information

The substance 2-aminobenzenesulphonic acid does not show acute toxicity effect by the oral,dermal and inhalation route.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of sulphanilic acid to mouse by the oral route.
GLP compliance:
not specified
Test type:
standard acute method
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: sulphanilic acid does not exhibits acute toxicity by the oral route.
Mortality:
Lethal dose ; 50 percent kill
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of sulphanilic acid in mouse was found to be >3200 mg/kg of body weight. Acute toxicity of sulphanilic acid to mouse indicates that sulphanilic acid does not exhibits acute toxicity by the oral route.
Executive summary:

The acute oral median lethal dose (LD50) of sulphanilic acid in mouse was found to be >3200 mg/kg of body weight. Acute toxicity of sulphanilic acid to mouse indicates that sulphanilic acid does not exhibits acute toxicity by the oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 200 mg/kg bw
Quality of whole database:
The data from read across substance is K2 level as the experimental study data has been obtained from an authorative handbook 'Industrial Hygiene and Toxicology'.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute toxicity: oral

No. of studies were reviewed for acute oral toxicity with Klimish rating 2 and 4 of the target (2-aminobenzenesulphonic acid) and read across substance for CAS: 88-21-1.

The results for target and read across substances are summarized as follows:

Sr.No

Endpoint

Effect values

Species/Strain

Sources

1.

LD50

1270.568 mg/kg bw

Rat

Predicted data from QSAR for target CAS:88-21-1

 

2.

LD50

>3200 mg/kg bw

Mouse

Experimental data from handbook ‘Industrial Hygiene and Toxicology ‘for read across substance CAS no.: 121-57-3

3.

LD50

2000 mg/kg bw

Rat (Sprague-Dawley)

Experimental data from study report ‘Ministry of Health & Welfare, Japan’ for read across substance CAS no.:

88-44-8

4.

LDLo

2500 mg/kg bw

Mouse

Experimental data from publication ‘Quarterly Journal of Pharmacy & Pharmacology’ for read across substance CAS no.: 3306-62-5

 

Based on the studies summarized in the above table for target(2-aminobenzenesulphonic acid) and read across substances the endpoint value was found to vary between LD50 =1270.568 mg/kg bw to >3200 mg/kg bw and LDLo =2500 mg/kg bw as above mentioned substances structurally similar to target substance it is considered that target substance exhibit same toxicological properties to their respective read across thus it is concluded that 2-aminobenzenesulphonic acid dose not exhibit acute toxicity by oral route as per the CLP criteria.

Acute toxicity: inhalation

For 2-aminobenzenesulphonic acid, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.000027 at 25 degC as well as the particle size distribution indicates that the majority particle size is 150 (62.80%) - 300 (17.83%) micro meter. Thus, exposure by inhalation route is also unlikely for 2-aminobenzenesulphonic acid given the comparatively larger size of the particulates.

Acute toxicity: dermal

Acute dermal toxicity is unlikely to occur since dermal absorption of 2-aminobenzenesulphonic acid is very low based on the value 0.00027 mg/cm2/event. Thus, given considerations, it is assumed that 2-aminobenzenesulphonic acid shall not exhibit acute dose toxicity by the dermal route.

Justification for selection of acute toxicity – oral endpoint

The acute oral median lethal dose (LD50) of sulphanilic acid in mouse was found to be >3200 mg/kg of body weight. Acute toxicity of sulphanilic acid to mouse indicates that sulphanilic acid does not exhibits acute toxicity by the oral route.

Justification for selection of acute toxicity – inhalation endpoint

For 2-aminobenzenesulphonic acid, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of  0.000027 at 25 degC as well as the particle size distribution indicates that the majority particle size is 150 (62.80%) - 300 (17.83%) micro meter. Thus, exposure by inhalation route is also unlikely for 2-aminobenzenesulphonic acid given the comparatively larger size of the particulates.  

Justification for selection of acute toxicity – dermal endpoint

Acute dermal toxicity is unlikely to occur since dermal absorption of 2-aminobenzenesulphonic acid is very low based on the value 0.00027 mg/cm2/event. Thus, given considerations, it is assumed that 2-aminobenzenesulphonic acid shall not exhibit acute dose toxicity by the dermal route.

Justification for classification or non-classification

The substance 2-aminobenzenesulphonic acid do not show toxicity effect for oral,dermal and inhalation route and thus will not be considered for further classification.