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EC number: 700-664-8 | CAS number: 486455-65-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 March 2001 - 26 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2S)-N,N'-dibutyl-2-(2-ethylhexanamido)pentanediamide
- EC Number:
- 700-664-8
- Cas Number:
- 486455-65-6
- Molecular formula:
- C21H41N3O3
- IUPAC Name:
- (2S)-N,N'-dibutyl-2-(2-ethylhexanamido)pentanediamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes. F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.4-2.5 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclaved wood (RCC Ltd, Fullinsdorf) and haysticks for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 33/00) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Haysticks (QS no. 11/01) provided by Eberle Nafag AG, CH-9200 Gossau
- Water: Community tap water from Fullinsdorf, ad libitum.
- Acclimation: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Air-conditioned with target ranges for room temperature 20 ± 3 °C
- Humidity (%): relative humidity 30-70 %
- Air changes (per hr): approximately 10-14 air changes per hour
- Photoperiod (hrs dark / hrs light): The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the light period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- On the day of treatment, the test material was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, as well as 7 days after application.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were not rinsed after instillation.
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
To evaluate the irritation potential of the test item (EEC Commission Directive 93/21/EEC, April 27, 1993), the mean values were calculated for each individual, using the scores between 24 and 72 hours.
The primary irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then divided by the number of data points.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test item to healthy rabbit conjunctivae resulted in a primary irritation score of 0.56. The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.56 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae.
No abnormal findings were observed in the cornea or the iris in any animal at any time point. Slight reddening of the conjunctivae was noted in two animals from 1 to 24 hours after treatment. Slight to moderate reddening was also observed in the other animal from 1 to 72 hours after treatment. Slight swelling of the conjunctivae was evident in all animals at the 1-hour reading. Slight reddening of the sclera was observed in all animals at the 1-hour reading and in one female this persisted up to 24 hours after treatment. A slight watery discharge was present in one female at the 1-hour reading.
All eye reactions had cleared within 7 days after treatment. No staining of the treated eyes by the test item was observed. White remnants of the test item were evident in the eye or conjunctival sac of all animals 1 hour after treatment. No corrosion was observed at any of the measuring intervals. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Any other information on results incl. tables
BODY WEIGHTS
The body weights of all rabbits were considered to be within the normal range of variability.
Body weight in grams | ||||
Animal No. | Sex | First Day of Acclimatization | Day of Treatment | Last Day of Observation |
88 | male | 2187 | 2468 | 2670 |
89 | female | 2063 | 2429 | 2648 |
90 | female | 2112 | 2423 | 2720 |
TABLE 1: EYE IRRITATION SCORES - INDIVIDUAL VALUES
Animal No. | Sex | Evaluation Interval | Corneal Opacity | Iris | Conjunctivae | Cumulative | Sclera | ||
Redness | Chemosis | Score | Mean | ||||||
88 | M | 1 hour | 0 | 0 | 1 | 1 | 2 | 2.33 | 1 |
89 | F | 0 | 0 | 1 | 1 | 2 | 1 | ||
90 | F | 0 | 0 | 2 | 1 | 3 | 1 | ||
88 | M | 24 hours | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
89 | F | 0 | 0 | 1 | 0 | 1 | 0 | ||
90 | F | 0 | 0 | 1 | 0 | 1 | 1 | ||
88 | M | 48 hours | 0 | 0 | 0 | 0 | 0 | 0.33 | 0 |
89 | F | 0 | 0 | 0 | 0 | 0 | 0 | ||
90 | F | 0 | 0 | 1 | 0 | 1 | 0 | ||
88 | M | 72 hours | 0 | 0 | 0 | 0 | 0 | 0.33 | 0 |
89 | F | 0 | 0 | 0 | 0 | 0 | 0 | ||
90 | F | 0 | 0 | 1 | 0 | 1 | 0 | ||
88 | M | 7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
89 | F | 0 | 0 | 0 | 0 | 0 | 0 | ||
90 | F | 0 | 0 | 0 | 0 | 0 | 0 |
TABLE 2: EYE IRRITATION SCORES - MEAN VALUES AFTER 24, 48 AND 72 HOURS
Animal No. | Sex | Corneal Opacity | N | Iris | N | Conjunctivae | Primary Eye Irritation Score | |||
Redness | N | Chemosis | N | |||||||
88 | M | 0 | 3 | 0 | 3 | 0.33 | 3 | 0 | 3 | 0.56 |
89 | F | 0 | 3 | 0 | 3 | 0.33 | 3 | 0 | 3 | |
90 | F | 0 | 3 | 0 | 3 | 1 | 3 | 0 | 3 | |
Mean score | 0 | 0 | 0.56 | 0 |
N = number of available data points
TABLE 3: EYE IRRITATION SCORES - ASSESSMENT ACCORDING TO EEC GUIDELINES
Evaluated intervals | Corneal Opacity | Iris | Conjunctivae | |
Redness | Chemosis | |||
24 hours | Not Irritating | Not Irritating | Not Irritating | Not Irritating |
48 hours | ||||
72 hours |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- According to Regulation (EC) No 1272/2008, the test material does not require classification as irritating to the eye.
- Executive summary:
The primary eye irritation potential of the test material was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.56 (max. 13).
The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.56 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae.
No abnormal findings were observed in the cornea or the iris in any animal at any reading.
Slight reddening of the conjunctivae was noted in two animals from 1 to 24 hours after treatment. Slight to moderate reddening was also observed in the other animal from 1 to 72 hours after treatment. Slight swelling of the conjunctivae was evident in all animals at the 1-hour reading. Slight reddening of the sclera was observed in all animals at the 1-hour reading and in one female this persisted up to 24 hours after treatment.
A slight watery discharge was present in one female at the 1-hour reading.
White remnants of the test item were evident in the eye or conjunctival sac of all animals 1 hour after treatment.
No staining of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. All eye reactions had cleared within 7 days after treatment.
According to Regulation (EC) No 1272/2008, the test material does not require classification as irritating to the eye.
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