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Registration Dossier
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EC number: 267-956-0 | CAS number: 67953-76-8
Endpoint summary
Administrative data
Description of key information
There are no in vitro or in vivo data on skin and eye irritation for HEDP-xK, therefore good quality data are read-across from the category member HEDP (2-3Na).
In a translation of a German report for the key skin irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 404 and unknown if in compliance with GLP, HEDP (2-3Na) was not irritating to intact skin, and was mildly irritating to scarified rabbit skin (Korn, 1987).
In a German summary translation of the key eye irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 405 not specified if in compliance with GLP, HEDP (2-3Na) was not irritating to rabbit eyes (Korn, 1987).
No data is available for respiratory irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- 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 - 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. - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January and February 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No information on GLP status
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Berger, Langburkersdorf
- Age at study initiation: No data
- Weight at study initiation: Average 3292 g
- Housing: Individually in boxes with hard bottoms
- Diet: 80 g
- Water: Ad libitum
- 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: January and February 1987 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration: 35% active substance - Duration of treatment / exposure:
- Eyes not rinsed.
- Observation period (in vivo):
- Four days.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- After each substance application, clinical observations and evaluations of each exposed eye were carried out after the following periods (controls were the untreated eyes): one hour, 1, 2, 3, 4 days post-instillation. The clinical observation and evaluation was finished on the 2nd day as no irritation or corrosion could be detected. The cornea was examined for a possible haze (degree of haze and size of the hazed area), the iris for macroscopically visible deviations as well as light response and finally the conjunctiva for inflammatory processes.
REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: conjunctival effects only.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: one day
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- After instillation of 0.1 mL of the technical product into one conjunctival sack of the rabbit a formation of weak redness of the conjunctiva could be observed only till day 1 post-instillation. The maximum score of “eye irritation points” was 2.0.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a German summary translation of an eye irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 405 not specified if in compliance with GLP, HEDP (2-3Na) was not irritating to rabbit eyes.
Reference
Table 1 Summary of irritation results.
Hour / day post-exposure |
Cornea (maximum 80 points) |
Iris (maximum 10 points) |
Conjunctiva (maximum 20 points) |
Eye irritation points (maximum 110 points) |
1 hour |
0 |
0 |
2.00 |
2.00 |
1 day |
0 |
0 |
0.33 |
0.33 |
2 day |
0 |
0 |
0 |
0 |
3 day |
0 |
0 |
0 |
0 |
4 day |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a translation of a German report for the key skin irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 404 and unknown if in compliance with GLP, HEDP (2-3Na) was applied to intact and scarified skin respectively of six Californian rabbits for four hours. The dose was 0.5 mL of a 25% active substance and any skin reactions were scored up to 13 days after the application. 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, however, had disappeared completely by day 10. It is concluded that HEDP (2-3Na) was not irritating to intact skin and mildly irritating to scarified rabbit skin (Korn, 1987).
In a supporting skin irritation study (reliability score 2), conducted prior to the adoption of OECD Test Guidelines and pre-GLP, HEDP (2 -3Na) was not irritating to rabbit skin (Younger Laboratories, 1971).
In a supporting skin irritation study (reliability score 1), conducted according to OECD Test Guideline 404 and in compliance with GLP, a single dose of HEDP-4Na was applied to intact skin of three New Zealand rabbits under semi-occluded application for four hours. The rabbits were evaluated for erythema and oedema formation at 24, 48 and 72 hours. It was concluded that sodium salt of HEDP is not irritating to the skin of rabbits (SafePharm Laboratories, 1995).
In a supporting well conducted skin irritation study (reliability score 1), conducted in a similar protocol to OECD Test Guideline 404 and pre-GLP, 0.5 mL of HEDP-4Na did not meet the criteria to be a skin irritant (BioDynamics Inc., 1985).
In a German summary translation of the key eye irritation study (reliability score 2), conducted using a protocol similar to OECD Test Guideline 405 and not specified if in compliance with GLP, 0.1 mL of a 35% active substance of HEDP (2-3Na) was applied to the eye of six Californian rabbits. The eyes were not rinsed prior to the treatment. Clinical observations and evaluations of each exposed eye were performed, however, as no irritation or corrosion could be detected by day 2, the evaluations stopped earlier. It was concluded that HEDP (2-3Na) is not irritating to rabbit eyes (Korn, 1987).
In a supporting eye irritation study (reliability score 2), conducted to a protocol similar to OECD Test Guideline 405 but pre-GLP, it was concluded that HEDP (2-3Na) was not irritating to the eyes of rabbits (Henkel, 1984). While this study was conducted on the registered substance, the limitations of it meant that an alternative study was selected as the key study. The result from this study support the overall conclusion that the registered substance is not irritating to eyes.
In a supporting eye irritation study (reliability score 1), conducted to OECD Test Guideline 405 and in compliance with GLP, 0.1 mL of HEDP-4Na was applied to the eye of one New Zealand White rabbit. Following observation of the ocular response, two additional animals were tested. It was concluded that sodium salt of HEDP is not irritating to the eyes of rabbits (SafePharm Laboratories, 1995).
In a well conducted supporting eye irritation study (reliability score 1), conducted using a protocol comparable to OECD Test Guideline 405 but pre-GLP, it was concluded that HEDP-4Na is mildly irritating to the eyes (BioDynamics Inc., 1985).
See read-across justification in IUCLID Section 13.
Justification for classification or non-classification
Based on the available read-across data for HEDP sodium salts and pH range of 6-8 for the registered substance HEDP-xK, no classification is required for potassium salts of HEDP for skin and eye irritation according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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