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EC number: 267-956-0 | CAS number: 67953-76-8
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:
- November and December 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No information on GLP status
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification in IUCLID Section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other:
- Remarks:
- Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- EC Number:
- 701-238-4
- Molecular formula:
- HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
- IUPAC Name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Manfred Berger, Langburkersdorf
- Age at study initiation: No data
- Weight at study initiation: Average 3090 g
- Housing: Individually in boxes with hard bottoms.
- Diet: 80 g per day
- Water: 200 mL per day
- Acclimation period: Two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 °C
- Humidity (%): 40-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: November and December 1986
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and scarified skin exposed
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 35% active substance - Duration of treatment / exposure:
- Four hours
- Observation period:
- 14 days
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Flank
- % coverage: No data (shaved/scarified area of 2.5 x 2.5 cm)
- Type of wrap if used: Aluminium foil and elastic tapes
REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: Draize
After each application, clinical observations and evaluations of each exposed skin area of each rabbit were made: one hour after removal of the substance as well as on 1, 2, 3, 6, 8, 10 and 13 days after application.
Both exposed intact and scarified skin areas were examined and evaluated. The untreated areas represented the respective control areas.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The intact skin showed no signs of skin irritation. On the scarified (slightly pre-damaged) skin, slight to moderate erythema with slight oedema were recognised. Those irritations disappeared completely by day 10. The calculated skin irritation index at one hour was 1.17, and 2.5 for the scarified skin, indicating the substance would be rated as slightly irritant. However, no skin irritation was observed in intact skin in any of the animals.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 1 Summary of irritation results over the 14 day observation period.
Hour / day post application |
Intact skin area (maximum 8 points) |
Scarified skin area (maximum 8 points) |
Skin irritation index (maximum 8 points) |
1 hour |
0 |
2.50 |
1.17 |
1 day |
0 |
1.67 |
0.83 |
2 |
0 |
1.67 |
0.83 |
3 |
0 |
1.00 |
0.50 |
6 |
0 |
0.50 |
0.25 |
8 |
0 |
0.17 |
0.08 |
10 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a translation of a German report on a skin irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 404 and unknown if in compliance with GLP, the HEDP (2-3Na) was not irritating to intact skin, and was mildly irritating to scarified rabbit skin.
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