Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize method
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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

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.