Neodecanoic acid, neodymium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)

EC Number:

600-768-2

Cas Number:

106726-11-8

Molecular formula:

C30H57NdO6

IUPAC Name:

neodymium(3+) 2-ethyl-2,5-dimethylhexanoic acid tris(2-ethyl-2,5-dimethylhexanoate)

Test material form:

solid

Details on test material:

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

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

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK or Interfauna UK Ltd.
- Weight at study initiation: 2.8, 3.2, and 3.4 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 45-64%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12 hours

IN-LIFE DATES: September 1985

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): volume of 100 µL (correlates to 75 mg)

Duration of treatment / exposure:

the treated eye was held closed for 1 second after application of the test item

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days after treatment

Number of animals or in vitro replicates:

3 animals

Details on study design:

tissues investigated: cornea (opacity and area of opacity), iris and conjunctivae (redness, edema, lacrimation)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1 hour after instillation in all three animals a slight redness (score 1.0) was observed that was due to the mechanical irritation of the solid test item in the eyes; no indication of irritation became obvious at the time points 24/48/72 hours and 7 days after treatment; the study was thus terminated after 7 days

Applicant's summary and conclusion

Executive summary:

In an eye irritation study on 3 rabbits performed in 1985 according to OECD 405 the solid test substance (volume 100 µL, according to 75 mg) was instilled in one eye of each rabbit. The other eye served as control. No eye irritation became obvious and the irritation score was thus 0.0 for the time points 24/48/72 hours after treatment.