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Diss Factsheets

Administrative data

Description of key information

The oral LD50 for male and female rats was greater than 5000 mg/kg bw. Metanilic acid wet (free acid) did not cause any formation of methemoglobin nor did it induce any HEINZ bodies in the blood in the oral toxicity study a female and a male cat.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, available as unpublished report, minor restrictions in design and/or reporting, but otherwise adequate for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 male and 5 female Wistar rats were administered by oral gavage 5000 mg/kg bw metanilic acid moist, free acid. Animals were observed during a 14 day observation period.
GLP compliance:
not specified
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: Winkelmann, Borchen
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: average initial weight 174g
- Housing: animals were housed in groups of 5 animals in Macrolon type III cages on dust-free wood pellets.
- Diet (e.g. ad libitum): During the experimental period, the animals received Altromin R 1324 (Manufacturer: Altromin GmbH, Lage, Germany) ad libitum.
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12, artificial light period 7.00 to 19.00 hours

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
5000 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: twice daily (once daily in the weekends and holidays)
- Other examinations performed: nature, onset, duration and intensity of clinical symptoms were recorded. If necessarry dead animals were removed. During the application and at the end of the 14 day observation period, the surviving animals were weighed individually. Sectioning at random.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: No symptoms
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
> 5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an oral toxicity study metanilic acid moist, free acid (5000 mg/kg bw) was administered by oral gavage to 5 male and 5 female Wistar rats (Bayer AG 1980). No signs of toxicity were observed during a 14 day observation period. The LD50 for male and female rats was greater than 5.0 g / kg body weight. Furthermore, in a GLP study, 3-Aminobenzenesulfonic acid was studied for oral toxicity in rats in a single dose toxicity test, according to OECD 401, at doses of 500, 1000 and 2000 mg/kg (NIHS 2008). The single dose toxicity test revealed an LD50 of above 2000 mg/kg for both sexes.
In a non-GLP, non-guideline, oral toxicity study a female and a male cat were administered by oral gavage 10 and 50 mg/kg bw respectively metanilic acid moist (free acid) (in water) (Bayer 1985). Drip blood was collected from an ear vein after 0, 3, 7, 24 and 30 hours. Determined were met-hemoglobin (Met-Hb, hemoglobin with Fe3+) and HEINZ bodies (HK). At a dose Ievel of 10 mg/kg body weight, loss of appetite was observed up to 8 hours after treatment. Otherwise, no abnormal signs or symptoms were observed. The percentage of met-hemoglobin was not increased at both doses. No increase in HEINZ bodies was observed.

Metanilic acid wet (free acid) did not cause any formation of methemoglobin nor did it induce any HEINZ bodies in the blood under the test conditions described.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered not to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480. However, 3 -aminobenzene sulphonic acid is listed to Annex VI of the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008; Cat. 4, H302, H312, H332.