Neodecanoic acid, neodymium salt

Endpoint summary

Description of key information

acute oral LD50 is > 2000 mg/kg bw

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

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Guideline:

other: EG-Richtlinie 84/449

Version / remarks:

Amtsblatt der Europäischen Gemeinschaften 27, 1984, L251, 96

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Name of test substance in the report: Neodym-Versatat
Appearance: solid
Molecular weight: 657 g/mole
Molecular formula: C30H57NdO6

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: about 9 weeks (males) to 14 weeks (females)
- Weight at study initiation: mean 171 g (males) and 176 g (females)
- Fasting period before study: 16 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 60% +/- 10%
- Photoperiod (hrs dark / hrs light): 12 hours

IN-LIFE DATES: From: 13.08.1985 To: 02.09.1985

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10/20 mL

Doses:

1000 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

higher doses were not applicable due to the limited solublilty of the test item in the vehicle
Observations:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily for clinical signs; body weighing before treatment, one week and two weeks after treatment
- Necropsy of survivors performed: yes

Sex:

male

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

males: on male died on day 8 after application of 1000 mg/kg bw; two males died within the first 2 days after application of 2000 mg/kg bw
females: no mortality

Clinical signs:

other: males: both doses led to a reduced general condition and piloerection females: 1000 mg/kg bw were well tolerated; 2000 mg/kg bw led to a reduded general condition

Gross pathology:

in the unscheduled deaths effects slight reddening was seen to the mucous membrane of the stomach and intestine

Executive summary:

In an acute oral toxicity study performed in 1985 the test item was given by oral gavage to 5 Wistar rats/sex in doses of 1000 and 2000 mg/kg bw. As vehicle DMSO was used that was applied in amounts of 10 and 20 mL/kg bw, respectively. Mortality was observed only in males at 1000 (1 male) and 2000 mg/kg bw (2 males). A reduced general condition was seen in all treated males and in females of the 2000 mg/kg bw group. The LD50 was determined in this study with >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

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 acute oral toxicity study performed in 1985 the test item was given by oral gavage to 5 Wistar rats/sex in doses of 1000 and 2000 mg/kg bw. As vehicle DMSO was used that was applied in amounts of 10 and 20 mL/kg bw, respectively. Mortality was observed only in males at 1000 (1 male) and 2000 mg/kg bw (2 males). A reduced general condition was seen in all treated males and in females of the 2000 mg/kg bw group. The LD50 was determined in this study with >2000 mg/kg bw.

Justification for classification or non-classification

Based on the available studies no classification is warranted for acute oral toxicity. No studies are available for acute dermal and acute inhalation toxicity.