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EC number: 619-232-4 | CAS number: 96624-52-1
- 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
The test item is neither a skin irritant nor a eye irritant.
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:
- Oct 05 - Oct 19, 1993
- 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
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Strain: Rabbit, IVA:NZW, males (m) and females (f)
Source: SAVO-Ivanovas, Kisslegg
Age: about 36 weeks
Initial Weight: 3,96 (3.36-4.67) kg
Total Number of Animals: 3 (2m, 1 f) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: paraffin oil
- Controls:
- not required
- Amount / concentration applied:
- 0,5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours after removal of patches and then daily up to day 14
- Number of animals:
- 2m, 1f
- Details on study design:
- Identification and adaptation
Healthy young rabbits were allocated to the different groups.The animals were kept in the experimental room for more than 7 days to allow for acclimatization.
Assignment
2 male and 1 female rabbit were assigned for this study.
Housing and diet
All rabbits were housed in an air-conditioned room of 39 m2 in the rabbit experimental station with daylight. They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2 , height: 38 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine cleaned before the start of the studies.
Temperature and humidity were measured using a thermo hygrograph (type 252, Wilhelm Lambrecht KG, Göttingen).
The room temperature varied from 19 to 21°C and the humidity from 33 to 57 %.
The rabbits received Altromin Standard Diet TPF(R) 2113, pellets and acidified, fully demineralized water from an automatic drinking device ad libitum.
The diet is checked periodically by an independent and German Government approved testing laboratory, according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
Vehicle
Name: Liquid paraffin
Observations for clinical symptoms
The rabbit was examined for skin alterations, behavior, and general condition 1 hour after removal of the patch, after 24, 48, 72 hours, and then daily up to experimental day 14.
Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations.
Grading scale for evaluation:
Erythema and eschar formation
Scores
--------------------------------------------------
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar
formation preventing grading of erythema 4
--------------------------------------------------
Maximum possible: 4
--------------------------------------------------
Edema formation
Scores
--------------------------------------------------
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well
defined by definite raising) 2
Moderate edema (raised approx. 1 mm) 3
Severe edema (raised more than 1 mm
and extending beyond area of exposure) 4
--------------------------------------------------
Maximum possible: 4
--------------------------------------------------
Total possible irritation score (maximum): 8
Mean score = Mean grading for erythema or edema of all the rabbits per time point
Mean cumulative score = Mean grading of all readings for erythema and edema per time point
Mean score per animal = Mean grading for each animal of erythema or edema (24, 48, and 72 hours after removal of the patches) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: see text for details
- Irritant / corrosive response data:
- The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations of the skin sites were performed daily for further 14 days.
In the primary skin irritation test, erythema (scores 1 and 2) were observed from day 2 - 14, and edema (scores 1 and 2) from day 3 - 10 of the study. In two rabbits scales were observed from day 8 - 12 of the study. - Other effects:
- No signs of systemic toxicity were detected. The body weight developent corresponded to that of the untreated rabbits of the same age. No mortality was observed during the course of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the result of the irritation scores, the test material has not to be classified as irritant for the skin.
- Executive summary:
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test material when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions.
This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
Study Design
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of liquid paraffin to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal. This animal showed signs of irritation (well defined erythema, edema, brittle skin, and scales) and no more animals were treated. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 14 days.
Results
No signs of pain were observed after administration. The body weight developent corresponded to that of the untreated rabbits of the same age. No mortality was observed during the course of the study.
In the primary skin irritation test, erythema (scores 1 and 2) were observed from day 2 - 14, and edema (scores 1 and 2) from day 3 - 10 of the study. In two rabbits scales were observed from day 8 - 12 of the study.
Conclusion
According to the result of the irritation scores, the test material has not to be classified as irritant for the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
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:
- key study
- Study period:
- Oct 05 - Oct 19, 1993
- 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:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Strain: Rabbit, IVA:NZW, males (m) and females (f)
Source: SAVO-Ivanovas, Kisslegg
Age: about 36 weeks
Initial Weight: 4.15 (3.86 - 4.34) kg
Total Number of Animals: 3 (2m, 1 f) - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0,1 g
- Observation period (in vivo):
- 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 5 of the experimental part.
- Number of animals or in vitro replicates:
- 2m, 1f
- Details on study design:
- -- Identification and adaptation
Healthy young rabbits were allocated to the different groups.The animals were kept in the experimental room for more than 7 days to allow for acclimatization.
-- Assignment
2 male and 1 female rabbit were assigned for this study.
-- Housing and diet
All rabbits were housed in an air-conditioned room of 39 m2 in the rabbit experimental station with daylight. They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2 , height: 38 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine cleaned before the start of the studies.
Temperature and humidity were measured using a thermo hygrograph (type 252, Wilhelm Lambrecht KG, Göttingen).
The room temperature varied from 19 to 21°C and the humidity from 33 to 57 %.
The rabbits received Altromin Standard Diet TPF(R) 2113, pellets and acidified, fully demineralized water from an automatic drinking device ad libitum.
The diet is checked periodically by an independent and German Government approved testing laboratory, according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
-- Preparation
Before the application, the test material was ground in a mortar using a pestle.
–- Administration and dose level
To ensure that only rabbits with normal eyes were included in the study, approximately 24 hours before treatment ophthalmological examinations were performed after instillation of a 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope according to Eisenhut (Basel). Animals with eye defects, injury or irritation were excluded.
0.1 g test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed. The right eye remained untreated and served as control. After instillation, the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed.
-- Observation for clinical symptoms
The rabbits were investigated for eye irritation and for changes in behavior and general condition 1 hour after treatment, and then after 24, 48, 72 hours and so on for a period of further 4 days.
All rabbits were weighed before the start of the study and on days 5 and 8.
Local changes of the eye were evaluated according to the recommendations of the OECD (see below). The classification followed the Appendix VI of the EEC Directive 79/831.
-- Evaluation of eye reactions
- Cornea Scores
A) Opacity-degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling
of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacrous area, no details of iris visible, size of pupil barely
discernible 3
Opaque cornea, iris not discernible through the opacity 4
B) Area of cornea involved not evaluated (Rating according to the DRAIZE method)
- Iris
A) Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperemia, or injection, any of these or combination
of any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction
(any or all of these) 2
- Conjunctivae Scores
A) Redness (refers to palpebral and bulbar conjunctivae,
cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3
B) Chemosis: lids and/or nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
C) Discharge (Rating according to the DRAIZE method )
No discharge 0
Any amount different from normal (does not include small
amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs,
and of a considerable area around the eye 3
Mean score of all animals = Mean grading for irritations of cornea, iris, and conjunctivae per time point
Mean score per animal = Mean grading for each animal of irritations of cornea, iris, and conjunctivae (1, 24, 48, and 72 hours after application)
Maximum value = Maximum grading of a sign of irritation within a period - Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 (CLP).
- Executive summary:
Purpose
The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a rational basis for risk assessment to the eye irritating potential of the test item in man.
Study Design
To test for eye irritation a test according to the OECD-Guidelines for Testing of Chemicals No. 405, the annex to Directive 79/8319 EEC, and the recommendations of DRAIZE (1959) was performed.
Results
No signs of irritation were observed at the cornea or iris. In one animal the conjunctivae showed redness (score 1) at the first reading. Later on, no signs of irritation were seen. Thereafter no signs of irritation were observed. The untreated eyes were unchanged.
Conclusion
No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 (CLP).
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous.
No signs of clinical toxicity were detected. No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and discharge (score 1) one hour after instillation of the test material. No abnormalities were detected in the untreated eyes.
Eve irritation of all animals (mean score):
24 h | 48 h | 72 h | |
Cornea (mean /max) | 0/0 | 0/0 | 0/0 |
Iris (mean / max) | 0/0 | 0/0 | 0/0 |
Conjunctivae (mean / max) | 0/0 | 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
Justification for selection of skin irritation / corrosion endpoint:
This study was performed according to GLP and the methods applied
are fully compliant with OECD TG 404.
Justification for selection of eye irritation endpoint:
This study was performed according to GLP and the methods applied
are fully compliant with OECD TG 405.
Justification for classification or non-classification
Based on the provided data, the test item is not classified skin/eye irritation/corrosion according to Regulation (EC) No 1272/2008.
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