Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 232-796-2 | CAS number: 9025-49-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Aspergillopepsin I was tested for skin and eye irritation in rabbits and and no dermal or eye irritation was observed.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive Annex I, II, III, and IV, Official Journal of the European Communities published in L 110 A, volume 36, 4 May 1993 § 3.2.6. I and § 3.2.5
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.2 - 3.6 kg
- Housing: The animals were kept in a PPO-plast cage (Noryl®, floor area: 4200 cm2) with perforated floor. The tray under the cage was cleaned 2 times a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 2 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Initial Test: 3 minutes, 1 hour, 4 hours
Confirmatory Tests: 4 hours - Observation period:
- After each patch removal (3 minutes, 1, and 4 hours) and at 1, 24, 48, and 72 after termination of exposure
- Number of animals:
- Initial Test: 1 female
Confirmatory Test: 2 females - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 5 cm
- Type of wrap if used: Each gauze patch was secured with adhesive tape and thereafter the circumferential area of the patches was fixed with Scanpore tape. Nobafix gauze was wrapped around the trunk to secure the dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water and mild soap
OBSERVATION TIME POINTS
- After patch removal (3 minutes and 1 and 4 hours) and 1, 24, 48, and 72 hours after termination of exposure
SCORING SYSTEM:
- Method of calculation: The scores for erythema and eschar formation and oedema formation for the 3 readings at 24, 48, and 72 hours were obtained and divided by 3. The results are the average scores for erythema and eschar formation and oedema formation. - 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:
- 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
- Irritant / corrosive response data:
- Initial Test: No reactions were observed at any test site or negative control site at any of the time points.
Confirmatory Test: Not reactions were observed at any test site or negative control site at any of the time points in one rabbit. In the second rabbit, no reactions were observed at the 3-minute or 1-hour application sites. Very slight erythema was observed at the 4-hour application site one hour after termination of exposure. No other reactions were observed at any other test site or negative control site at any of the time points. - Other effects:
- No clinical signs were observed in the animals during the daily observations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean score for erythema was 0.0 and the mean score for oedema was 0.0. The test substance was not irritating to the skin.
- Executive summary:
The acute dermal irritant effect of the test substance was carried out according to OECD Guideline 404. No clinical signs were observed in the animals during the daily observations, except for the skin reactions observed at the test sites. The study was initiated with one rabbit, and as no skin reactions were observed in this animal at any of the observation time points, two additional animals were included in the study. Very slight erythema was observed in one animal at the 4-hour application site one hour after termination of exposure. No other reactions were observed at any test site or negative control site in any of the animals at any time points during the study. The mean score for erythema was 0.0 and the mean score for oedema was 0.0.
Reference
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- One animal used in previous eye irritation study as control. Deviation did not affect the outcome of the study as a 17-day washout period allowed prior to inclusion on this study. Also, similar reactions observed in all treated animals during the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- One animal used in previous eye irritation study as control. Deviation did not affect the outcome of the study as a 17-day washout period allowed prior to inclusion on this study. Also, similar reactions observed in all treated animals during the study.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 2.7 - 3.8 kg
- Housing: The animals were kept individually in PPO-plast cages (Noryl®, floor area: 4200 cm2) with perforated floor. The tray under the cage was cleaned 2 times a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 46 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - 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 - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
TOOL USED TO ASSESS SCORE: Fluorescein stain was used after the 24-hour observation. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- At the examination 1 hour after exposure, conjunctiva appeared red (some blood vessels were definitely hyperaemic – equal to score 1) in the initial animal. This reaction persisted the following day (24 hours after exposure). However, it was considered ethically acceptable to proceed with 2 additional animals as only very mild reactions had been observed in the initial animal. Similar scoring of conjunctival redness was observed in the 2 additional animals at the examination 1 hour after exposure. At all other examinations, all animals appeared normal.
- Other effects:
- No clinical signs were observed during the daily observations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Only slight signs of irritation were observed at 1 and 24 hours in one rabbit. All eyes were normal by 48 hours.
- Executive summary:
The eye irritant effect of the test substance was investigated according to the method OECD Guideline 405. Three female albino rabbits were used in the study. Initially, one animal was exposed to 0.1 mL of the test substance in the left eye. The right eye remained untreated and served as control. Both eyes of all animals were examined and the changes were graded according to a numerical scale 1, 24, 48, and 72 hours after treatment.
No clinical signs were observed in the animals during the daily observations. At the examination 1 hour after exposure, conjunctiva appeared red (some blood vessels were definitely hyperaemic – equal to score 1) in the initial animals. The reaction persisted the following day (24 hours after exposure). However, it was considered ethically acceptable to proceed with two additional animals as only very mild reactions had been observed in the initial animal. Similar scoring of conjunctival redness was observed in the two additional animals at the examination 1 hour after exposure. At all examinations, all animals appeared normal. Mean values, based on the results from the 24, 48, and 72 hour readings were calculated. The mean values were 0.0, 0.0, 0.0, and 0.1 for cornea opacity, iris lesion, chemosis of conjunctiva, and redness of conjunctiva, respectively.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The skin and eye irritation potential of Aspergillopepsin I has been tested according to OECD guidelines and in compliance with GLP. The conclusion was that it did not exert any skin and eye irritation.
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.