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Registration Dossier
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EC number: 482-670-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1 September 2006 to 20 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was performed according to internationally recognised guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the temperature and relative humidity sometimes outside of the target ranges (this minor deviation was not considered to have compromised the validity or integrity of the study).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see higher
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- see higher
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: on the day of treatment, the animals had a mean body weight of 2.8 ± 0.2 kg
- Housing: the animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm)
- Diet: free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: from 12 September 2006 (day of treatment of the first animal) to 17 September 2006 (end of the observation period)
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: 500 mg - Duration of treatment / exposure:
- The test item was first evaluated on a single animal. The durations of exposure were 3 minutes, 1 hour and 4 hours.
Since the test item was neither severely irritant nor corrosive on this first animal, it was then applied for 4 hours simultaneously to two other animals. - Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: anterior left flank (application for 3 minutes), anterior right flank (application for 1 hour) or posterior right flank (application for 4 hours)
- % coverage: approximately 6 cm2
- Type of wrap if used: gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes (any residual test item was wiped off by means of a dry cotton pad
- Time after start of exposure: 4 hours
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) to slight eschar formation (injuries in depth) -> 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 (raised approximately 1 millimetre) -> 3
. severe oedema (raised more than 1 millimetre and extending beyond area of exposure) -> 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: NOt applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After a 3-minute and a 1-hour exposure (one animal):
No cutaneous reactions were observed.
After a 4-hour exposure (three animals):
A very slight erythema (grade 1) was noted in 2/3 animals on day 1 only.
No other cutaneous reactions were observed thereafter.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.
Any other information on results incl. tables
Table 1: Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number |
Dermal irritation |
Scores |
Mean irritation score (1) |
Interpretation (+) or (-) |
|||
1h |
24h |
48h |
72h |
||||
646 |
Erythema Edema Other |
0 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
608 |
Erythema Edema Other |
1 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
609 |
Erythema Edema Other |
1 0 * |
0 0 * |
0 0 * |
0 0 * |
0.0 0.0 |
(-) (-) |
(1) mean of scores on days 2, 3 and 4
(+) = irritant according to E.E.C. criteria
(-) = non-irritant according to E.E.C. criteria
* = none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neodymium tris(di-2-ethylhexylphosphate) is not considered to be a skin irritant in the rabbit.
- Executive summary:
In a primary dermal irritation study performed according to OECD 404, EC B.4, US/EPA/OPPTS 870.2500 and GLP (CIT report No. 32230 TAL, 2007), scored as validity 1 according to Klimisch criteria, 3 male New Zealand White rabbits were dermally exposed to 0.5 g of neodymium tris(di-2-ethylhexylphosphate) applied on the skin of flanks and maintained under semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 h after removal of the dressing by calculating dermal irritation scores, based on the grading of cutaneous erythema and edema.
After a 3-minute and a 1-hour exposures (one animal), no cutaneous reactions were observed.
After a 4-hour exposure (three animals), a very slight erythema was noted in 2/3 animals on day 1 only. No other cutaneous reactions were observed thereafter.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.
The test substance was considered as non-irritant to the skin. No classification for skin irritation is warranted based on the observed cutaneous reactions following a 4-hour exposure, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable. It satisfies international guideline requirements for acute dermal irritation or corrosion.
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