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Description of key information

A crude form of the analogue substance showed no acute oral toxicity in rats. The analogue contains a phenol instead of a naphthol ring. The putative ester hydrolysis product pf the target substance is 2,6-naphthalenedicarboxylic acid. Data on absence of acute oral toxicity of this substance was reported in the NICNAS dossier. Therefore, it is considered safe to apply read-across.

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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment. Test itm purity less than 80%.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
96/54/EC
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: approx. 14 - 18 weeks
- Weight at study initiation: Animals of comparable weight (202-217 g)
- Fasting period before study: 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät (Maus / Ratte Haltung ("GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% CMC-solution
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED:
- Concentration: 20g/100 mL,
- Administration volume: 10mL/kg
Doses:
2000 mg/kg (containing 1320 mg/kg bw of main component)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Frequency of observations: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.
Sex:
female
Dose descriptor:
LD0
Effect level:
> 1 320 mg/kg bw
Based on:
test mat.
Remarks on result:
other: adjusted for content of main component.
Mortality:
No mortality occurred.
Clinical signs:
other: - Clinical observation in the second 2000 mg/kg administration group revealed impaired general state, dyspnoea and piloerection and were observed from hour 1 until including hour 5 after administration. - No clinical observations were observed during clin
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study.
Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
1 320 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

Justification for classification or non-classification