2-Naphthalenecarboxylic acid, 6-[[[4-[(1-oxo-2-propen-1-yl)oxy]butoxy]carbonyl]oxy]-

Endpoint summary

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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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