Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 606-274-3 | CAS number: 192389-48-3
Endpoint summary
Administrative data
Description of key information
Skin irritation (rabbit): not irritating
Eye irritation (rabbit): not irritating
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 4.5-5 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the surrounding untreated skin served as control
- Amount / concentration applied:
- Amount: 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours as well as 4 to 6 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: no residual test item had to be removed
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: mean score after 72 hours: 1.0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.33
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- edema score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
Classification: not irritating- Executive summary:
In a dermal irritation study according to OECD TG 404 KURG 101 was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 male rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours as well as after 4 to 6 days using the Draize scale. The mean irritation index for erythema was 0.44 of max. 4 (0.0-1.0), the mean irritation index for edema was 0.0 of max. 4. Signs were fully reversible in all animals within 6 days. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the skin".
Reference
Table 1: Summary of irritant effects on the skin (Exposure: 4 hours)
Observation time (after patch removal) |
1 h |
24 h |
48 h |
72 h |
day 4 |
day 5 |
day 6 |
Animal 1 |
|
|
|
|
|
|
|
Erythema (redness) |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
Oedema formation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Animal 2 |
|||||||
Erythema (redness) |
0 |
1 |
0 |
0 |
- |
- |
- |
Oedema formation |
0 |
0 |
0 |
0 |
- |
- |
- |
Animal 3 |
|||||||
Erythema (redness) |
0 |
0 |
0 |
0 |
- |
- |
- |
Oedema formation |
0 |
0 |
0 |
0 |
- |
- |
- |
0 = no pathological findings; - = no examination
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 6.5 months
- Weight at study initiation: 2.2-2.6 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control
- Amount / concentration applied:
- Amount: 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours post application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not specified
SCORING SYSTEM: according to DRAIZE
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
Classification: not irritating- Executive summary:
In an eye irritation study according to OECD TG 405 KURG 101 was instilled into the conjunctival sac of one eye of 3 male rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. No irritation effects were seen at cornea, iris or conjunctivae during the observation period. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the eyes".
Reference
A single application of 0.1 mL KURG 101 per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes at the observation time points 1, 24, 48 and 72 hours post application.
There were no systemic intolerance reactions.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a dermal irritation study according to OECD TG 404 KURG 101 was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 male rabbits (Leuschner, 2002a). Skin irritation was assessed after 1, 24, 48 and 72 hours as well as after 4 to 6 days using the Draize scale. The mean irritation index for erythema was 0.44 of max. 4 (0.0-1.0), the mean irritation index for edema was 0.0 of max. 4. Signs were fully reversible in all animals within 6 days. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the skin".
Eye irritation
In an eye irritation study according to OECD TG 405 KURG 101 was instilled into the conjunctival sac of one eye of 3 male rabbits (Leuschner, 2002b). Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. No irritation effects were seen at cornea, iris or conjunctivae during the observation period. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the eyes".
Justification for selection of skin irritation / corrosion endpoint:
Only one key study available
Justification for selection of eye irritation endpoint:
Only one key study available
Justification for classification or non-classification
Based on the study results (not irritating to skin and eyes) a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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.
