Registration Dossier
Registration Dossier
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EC number: 233-138-7 | CAS number: 10043-27-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Final report: 04-APR-1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No certificate of analysis of the test substance. 4 animals used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Terbium trinitrate
- EC Number:
- 233-138-7
- EC Name:
- Terbium trinitrate
- Cas Number:
- 10043-27-3
- Molecular formula:
- HNO3.1/3Tb
- IUPAC Name:
- terbium trinitrate
- Test material form:
- other: colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): Nitrate de terbium
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 kg to 3.5 kg
IN-LIFE DATES: From: 11-MAR-1980 To: 14-MAR-1980
No other information were available.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 25 (= 1 hour after removal of disc) and 72 hours after application
- Number of animals:
- 4 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: small discs of 3 cm diameter
- Type of wrap if used: semiocclusive dressing
- Skin: intact or scarified (only the intact skin was taken into account for the result)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
- Erythema:
No erythema -> 0
Very slight erythema (barely perceptible) ->1
Slight erythema (perceptible) -> 2
Moderate to severe erythema -> 3
Severe erythema with eschar formation:
* slight -> 4
* extended (more than 50% of the surface of application) -> 8
- Oedema Formation:
No oedema -> 0
Very slight oedema (barely perceptible) -> 1
Slight oedema (edges of area well defined by definite raising) -> 2
Moderate oedema (raised approximately 1 mm) -> 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) -> 4
- Primary Dermal Irritation Index = (Sum of individual Erythema scores + Sum of individual Edema scores) / 16
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 8
- Reversibility:
- other: no information
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- other: no information
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 25 and 72 hours
- Score:
- 0.687
- Max. score:
- 12
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Intact skin
Any other information on results incl. tables
Table 1: Summary table of individual irritation scores for intact skin
Rabbits N° |
25 hours |
72 hours |
Total |
||||
Erythema |
Oedema |
Total |
Erythema |
Oedema |
Total |
(25 + 72 h) Er. + oed. |
|
159 |
1 |
0 |
1 |
1 |
0 |
1 |
2 |
160 |
1 |
0 |
1 |
1 |
0 |
1 |
2 |
161 |
2 |
0 |
2 |
0 |
0 |
0 |
2 |
162 |
2 |
1 |
3 |
1 |
1 |
2 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Terbium trinitrate was a slighty irritant for the skin but it was not classified for skin irritation.
- Executive summary:
In a primary dermal irritation study, 4 New Zealand rabbits were dermally exposed to 0.5 mL of terbium trinitrate applied on a disc of 3 cm diameter maintened under semi-occlusive dressing for 24 hours. Animals were then observed for up to 72 hours. Irritation was scored after 25 and 72 hours after removal of the dressing by calculating dermal irritation scores, based on the grading of cutaneous erythema and edema.
Very slight to slight erythema and/or none to slight oedema were observed.
Terbium trinitrate was a slighty irritant for the skin but it was not classified for skin irritation.
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