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

Endpoint summary

Description of key information

The hazard is derived from an analogue substance that contains all relevant structural features related to reactvity and pH. The lower purity of the test substance is considered acceptable since the effects were clearly below the thresholds of classification and labelling for the next higher hazard class. The target substance is considered to be not irritating to skin and irritating to eyes (GHS Cat 2A).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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other: GLP-compliant guideline study, available as unpublished report, Test itm purity less than 80%., fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24 2000

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 6 - 7 months
- Weight at study initiation: 3.76 - 3.91 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung ("GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

minimally moistened

Controls:

other: untreated skin of the animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g (ca 0.3g adjusted for purity)

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 (2 males and 1 female)

Details on study design:

TEST SITE
- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Area of exposure: 2.5 cm X 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation of skin reactions is performed according to the quoted guidelines.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Moderate erythema (grade 2) was observed in all animals immediately after removal of the patch. Slight erythema (grade 1) persisted in 2 animals up to 1 hour and in 1 animal up to 24 hours after removal of the patch.
- No other cutaneous reactions were observed during the study.
- The cutaneous reactions were reversible in 2 animals within 24 hours and in 1 animal within 48 hours after removal of the patch.
- Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0 for edema.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non-guideline study, available as unpublished report, restrictions in design/reporting but adequate for assessment.Test itm purity less than 80%.

Qualifier:

no guideline available

Principles of method if other than guideline:

HET-CAM in vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs).

GLP compliance:

no

Species:

other: chorioallantoic membrane of fertilized hen eggs

Duration of treatment / exposure:

3 and 5 minutes

Number of animals or in vitro replicates:

3 eggs

Details on study design:

Tested irritation parameters were haemorrhagia and coagulaton. Time (seconds) of appearance as well as grading of effects (0-3) were noted.

Irritation parameter:

other: appearance of coagulation

Basis:

mean

Time point:

other: 180 and 300 sec

Score:

0

Remarks on result:

other: No coagulation occurred

Irritation parameter:

other: appearance of haemorrhagia

Basis:

mean

Time point:

other: 180 and 300 sec

Score:

0

Remarks on result:

other: No haemorrhagia occurred

Interpretation of results:

other: not corrosive

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Effects on eye irritation: irritating