Registration Dossier
Registration Dossier
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EC number: 219-949-9 | CAS number: 2580-78-1
Toxicological information
Endpoint summary
Administrative data
Description of key information
The test substance did not show relevant skin or eye irritating effects
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:
- supporting study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study according to FDA guideline without GLP
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- Body weight: 1.5 to 2 kg
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL of a 5% and a 10% preparation to shaved and abraded skin each
- Duration of treatment / exposure:
- Single treatment: 24 h exposure
Repeated treatment: 5 repeated daily administrations - Observation period:
- 24, 48, and 72 hours after start of treatment (= 0, 24, 48 hours after patch removal)
- Number of animals:
- 6
- Details on study design:
- two areas of 3 cm x 3 cm were shaved, one of these scarified with a scarificator
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- shaved areas
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- all concentrations did not show any signs of irritation with single or repeated treatment on the shaved rabbit skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05. Feb to 08 Feb 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occusive scarifized and intact skin
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Source: Hoechst AG
Food: ERKA 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Weight: 1.5 to 2 kg
In-life date: 05. Feb to 08 Feb 1979 - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded (3x3 cm) and shaved (3x3 cm) skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted, 0.5 mL on 2.5 cmx2.5 cm gauze pads
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure shaved and scarified skin: 2.5x2.5 cm
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: 6 to 8 cm wide PVC sheeting covered by elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM: FDA Federal Register 38, No 187
Erythema and eschar formation (EEF) :
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
Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4
Mean value of 6 animals
Primary Irritation Index (PII) = EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved / 4
EVALUATION:
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant - Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24+72 h
- Score:
- 0.8
- Max. score:
- 8
- Irritant / corrosive response data:
- Two rabbits still showed a minimal erythema (score 1) at 72 hours.
- Other effects:
- In two rabbits dry skin was observed at 48 and/or 72 hours.
- Interpretation of results:
- not irritating
- Remarks:
- based on evaluation of shaved skin Criteria used for interpretation of results: EU
- Conclusions:
- EU Classification: not irritating
FDA evaluation: slightly irritant
Referenceopen allclose all
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:
- supporting study
- Study period:
- 02 to 08 February 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187
- Principles of method if other than guideline:
- Federal Register 38, No. 187
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- Himalayan Albino Rabbits (Albino Russenkaninchen)
Food: ERKA 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% and 5% in 0.9% NaCl solution - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 144 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, 72, and 144 hours after test item application by means of a magnifying lens. At 24 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
- Irritation parameter:
- cornea opacity score
- Remarks:
- 5% and 10% solution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 5% and 10% solution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 5% and 10% solution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 5% and 10% solution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification according to EU: no classification
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 to 08 February 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187
- Principles of method if other than guideline:
- Federal Register 38, No. 187
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Food: ERKS 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 28
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 hours
- Score:
- 22
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 14
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 8
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 110
- Irritant / corrosive response data:
- All animals: Nictitating membranes and conjunctive bluish stained up to 24 hours
Cornea minimally bluish stained in 5 rabbits on Day 1, still visible in 3 rabbits on Day 3. Due to the short post-observation period an the fact that the staining proved already to be reversible in 2 rabbits up to the end of the observation time. Full reversibility of the staining within a 21 day post-observation time is very likely. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification according to EU: no classification necessary
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
