[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

29 Oct - 12 Nov 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

For the read-across justification see section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

The test substance was prepared into a suspension of 20% (w / v) using corn oil (Nacalai Tesque) on the day of administration and used as a sample to be administered. It was confirmed that the test substance in the administered sample was uniform and stable, and that the administered sample used in this test contained a predetermined amount of the test substance.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: female: ~90 g; male: ~100 g
- Fasting period before study: 18 hours
- Housing: metal wire floor cage
- Diet (ad libitum): solid food (CE-2, Clea Japan)
- Water (ad libitum): tap water
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 - 24.3
- Humidity (%): 54 - 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Samples were prepared and administered in suspension
- Amount of vehicle (if gavage): 20 % (w/v)
- Justification for choice of vehicle: test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
The dose was calculated based on the body weight measured immediately before administration, and forced using a rat gastric tube.

Doses:

2000 mg/kg bw (based on results of preliminary study)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations: once daily and weighing: on days 0, 2, 4, 8, 11 and 15
- Necropsy of survivors performed: yes

Preliminary study:

In a preliminary test, three concentrations (20, 200, 2000 mg/kg bw) were tested in male rats and the effect was observed for 8 days. Soft feces excretion was observed but no death.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred of either males or females in the treated groups.

Clinical signs:

other: No effects on general condition were found.

Gross pathology:

Nothing abnormal was detected in gross pathology.

Other findings:

As a change in general condition, excretion of loose stool was observed in 4 males and 4 females in the 2000 mg / kg group from 30 minutes to 6 hours after administration. However, in the solvent control group to which corn oil was administered, similar changes were observed in all males and 4 females within the same time period. Therefore, it was judged that this change was due to solvent ingestion and did not suggest the toxicity of the test substance.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

The substance is a solid with low risk of dust formation. Thus the oral and dermal routes are considered to be the most likely routes of exposure.

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of 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:

comparable to guideline study with acceptable restrictions

Justification for type of information:

For the read-across justification see section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

no

Principles of method if other than guideline:

The study was performed in accordance with the Hazleton Manual of Standard Operating Procedures as applied to the client procedure supplied ( Procter and Gamble Standard Procedure No. 10 for Toxicological Evaluation) dated 24th June 1977.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Buxted Rabbit Co. Ltd, Great Totease Farm, Buxted, Nr. Uckfield, Sussex
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually in grid floor cages
- Diet (ad libitum): Standard Rabbit Diet
- Water (ad libitum): drinking water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ambient with a lower limit of 14
- Photoperiod: natural lighting conditions

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 25% of the total body surface (on the back)
- Type of wrap if used: gauze pads ( 80 x 120 mm) and secured by adhesive strapping. Each animal was placed into a Newman harness.

REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after administration with a wet disposable paper towel

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily for mortality and signs of toxicity for the 14 days following administration
- Frequency of observations to evaluate skin reactions: immediately after removal of the patches and daily for the next two weeks
- Frequency of weighing: once before administration of the test substance and thereafter on day 14
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male animal was found dead on day 7 after treatment. Laboured breathing was noted in this animal on the day before death (Day 6). Severely consolidated lungs were noted at necropsy and death was not considered to be related to treatment.

Clinical signs:

other: Slight diarrhoea was noted in one female animal ( No. 893) on day 3 after treatment. All other animals appeared normal throughout the observation period.

Gross pathology:

Necropsy of all surviving animals revealed no macroscopic abnormalities. One animal received for necropsy on day 7 showed severe consolidation of the lungs.

Other findings:

Erythema, ranging from slight to moderate in degree, was noted on removal of the adhesive dressing. The erythema was maintained and became severe in degree in one female animal 7 days after treatment. Four animals showed slight and moderate desquamation.
Slight oedema and eschar formation were also noted in some animals during the first week of observation.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 dermal was determined to be > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw