Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 November 1990 - 8 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
publication
Title:
Acute Toxicological Evaluation of Erbium Oxide
Author:
Lambert, C.E., Barnum, E.C. and Shapiro, R.
Year:
1993
Bibliographic source:
Int. J. Toxicol., 12(6): 619

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FHSA 16 CFR 1500.41
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Appearance: pink powdered solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimation period: 12 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C

IN-LIFE DATES: From: 5 November 1990 To: 8 November 1990

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of the test material was placed on each of the test sites (i.e. abraded and intact skin).
Duration of treatment / exposure:
24 hours
Observation period:
72 hours. Evaluation occurred 24 and 72 hours after exposure.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² (two per rabbit, one intact and one abraded).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently wiped clean of any residual test material.
- Time after start of exposure: after 24 hours of exposure.

SCORING SYSTEM:

Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Abraded skin
Irritant / corrosive response data:
All sites were clear of irritation during the test period.
Other effects:
All animals appeared active and healthy.

Any other information on results incl. tables

Table 1 Primary Dermal Irritation (PDI) Scores - Individual Results

Rabbit

24 hours

72 hours

Abraded

Intact

Abraded

Intact

7740

7741

7742

7743

7744

7745

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

Total

0/0

0/0

0/0

0/0

Mean

0/0

0/0

0/0

0/0

Key: erythema and eschar / oedema

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
Executive summary:

The primary skin irritation potential of the test material was investigated in a study which was broadly conducted in accordance with the FHSA guideline 16 CFR 1500.41.

During the study 0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure.

All sites were clear of irritation during the test period and the Primary Dermal Irritation Index was 0.0.

Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.