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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 248-053-0 | CAS number: 26850-47-5
- 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 did not cause any skin effects in an acute dermal irritating study according OECD test guideline 404.
Several in vivo eye irritation studies with the target substance are available. One conducted according OECD 405 was considered key study. Two studies were disregarded, as the obervation time lasted only 7 days despite the fact that not all effects were reversed. Concsequently, it is not possible to use them for classification according to CLP. Based on the available data and the assessment of the results of the key study, the test substace is classifies "Category 2" irritating to eyes.
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:
- 1989-08-29 to 1989-09-18
- 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
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Dr. K. Thomae GmbH Chemisch-pharmazeutscieh Fabrik D-7950 Biberach/Riss
- Acclimatisation period: at least 5 days
- Housing: one animal per cage at 20 ± 3°C, 30-70% relative humidity and 12 hours light cycle day
- Diet: ad libitum Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of test substance applied
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm²
- % coverage: full
- Type of wrap if used: covered with aluminum foil (approx. 36 cm2) and held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 0
- Remarks on result:
- not determinable
- Remarks:
- due to colouration of the skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The indiviual scores are presented in Table 1 (see box "Any other information on results incl. tables"). No erythema scores according to Draize were awarded due to colouration of the skin by the test substance for the first 24 hours. From 48 hours to 72 hours no reactions were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.
- Executive summary:
In a primary dermal irritation study, three female New Zealand White rabbits (approx. 12 -14 weeks old, 2160 - 2990 g) were dermally exposed to 0.5 g of the test item on a moistened gauze patch to the shaved flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize. In this study, the test item is not a dermal irritant.
Reference
Table 1: Individual skin reaction score
|
Erythema |
Edema |
||||
Animal number |
660/F CF/TF |
954/F CF/TF |
976/F CF/TF |
660/F CF/TF |
954/F CF/TF |
976/F CF/TF |
After 1 h |
0/* |
0/* |
0/* |
0/0 |
0/0 |
0/0 |
After 24 h |
0/* |
0/* |
0/* |
0/0 |
0/0 |
0/0 |
After 48 h |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
After 72 h |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Mean 24-72 h |
0/0# |
0/0# |
0/0# |
0/0 |
0/0 |
0/0 |
CF= control flank TF = test flank
M = male F = female
* = dark blue staining # = mean 48 - 72 hours
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:
- 1995-07-25 to 1995-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals
- Source: Charles River, Stolzenseeweg 32-36 D-88353 Kisslegg
- Number of Animals/test: 1 mal; 2 females
- Age at treatment: 15 weeks
- Bodyweight at start of treatment: 2.7 kg (male); 2.4-2.8 kg (females)
- Acclimatization: 5 days
- Housing: one animal per cage under standardized conditions
- Diet (e.g. ad libitum): ad libitum Kilba 341, Batch no 90/95 rabbit maintenance diet (“Kilba”,Klingentalmühle A, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, tap-water from Ittingen
Environmental Conditions
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Photoperiod (hrs dark/hrs light): 12/12, music during light period
- Air changes per hour: 10-15 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g test substance
- Observation period (in vivo):
- examination after 1 h, 24h, 48h, 72 h, 7 days and 14 days
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- Treatment:
The eyes of the animals were examined for intactness once, one day prior to test article administration. Only those animals with no signs of ocular injury or irritation were used on the test.
On the test day, 0.1 g of the test article (undiluted) 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 gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
In case of equivocal results when comparing the treated and untreated eyes, the illustration guide from the Consumer Product Safety Commission Washington, D.C. 20207 was used for additional control purposes (Washington, 1977).
Irritation Scores:
The eyes of each animal were examined for ocular irritation approximately 1, 24, 48, and 72 hours, as well as 7 and 14 days after administration. Any findings ascertained during examination were recorded and the numerical irritation scores were assigned thereafter based upon the severity of the individual findings. Therefore the description of observed finding may differ slightly from the respective numerical irritation scores. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The test article showed a primary irritation score of 4.00, when applied to the conjunctival sac of the rabbit eye. Slight to moderate chemosis and/or reddening of the conjunctivae was noted in all animals, in most cases combined with hyperemia of the scleral blood vessels and discharge. These findings were reversible by day 14 after administration.
At 72 hours after administration a delay/reduction of the iridic light reflex was noted in one rabbit only- Re-examination on day7 revealed no abnormalities.
Blue and/or violet staining of the cornea, conjunctivae and/or sclera was noted up to and including the seventh day after administration. The duration of staining varied between animals and tissues, but was fully reversible in all cases. Staining was no longer evident in any animal (with insignificant exceptions of periocular fur) after 14 days of observation.
A corneal opacity was noted in one rabbit from 24 to 72 hours after administration. This finding was no longer present after seven days. No corrosion (i.e. visible roughening of the epithelium) of the cornea was observed at any of the reading times.
For detailed results see Table 1 (Box: any other information on results, incl. tables) - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the fully reversibility of the staining and other relvant findings and the conjunctival redness score of 2 in two of the three rabbits, the test material is classified as "Category 2" (irritating to eyes).
- Executive summary:
In a primary eye irritation study according to OECD 405, 0.1 g of the test substance was instilled into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male/ 2 females). The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 14 days after test article application. Irritation was scored by the method of Draize. The scores of each animal at 24, 48 and 72 hours were used for calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48, and 72 hours and then dividing the resulting total by the number of figures. It was found to be 4.00 (max.13). Chemosis and/or reddening of the conjunctivae, hyperemia of the scleral blood vessels and discharge were reversible by day 14 after administration.
Reference
Table 1: According to EEC Commission Directive 93/21/EEC (April 27, 1993), the mean values of the scored for each type of lesion calculated for each animal separately:
Animal No. |
Mean values 24-72- hours |
|||
Cornea Opacity |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
|
22, male |
0.00 |
0.00 |
1.67 |
1.33 |
23, female |
2.00 |
0.33 |
2.00 |
1.33 |
24, female |
0.00 |
0.00 |
2.00 |
1.33 |
Table 2: Eye irritation scores
Animal |
sex |
|
Cornea opacity |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Cumul. Score |
Mean Cumul. Score |
1 hour |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
- |
2* |
2 |
2.00 |
23 |
F |
Not rinsed |
0 |
0 |
- |
2* |
2 |
|
24 |
F |
Not rinsed |
0 |
0 |
- |
2* |
2 |
|
24 hours |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
2* |
2* |
4 |
4.67 |
23 |
F |
Not rinsed |
2* |
0 |
2* |
2* |
6 |
|
24 |
F |
Not rinsed |
0 |
0 |
2* |
2* |
4 |
|
48 hours |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
2* |
1 |
3 |
3.67 |
23 |
F |
Not rinsed |
2* |
0 |
2* |
1 |
5 |
|
24 |
F |
Not rinsed |
0 |
0 |
2* |
1 |
3 |
|
72 hours |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
1 |
1 |
2 |
3.67 |
23 |
F |
Not rinsed |
2* |
1* |
2* |
1 |
6 |
|
24 |
F |
Not rinsed |
0 |
0 |
2* |
1 |
3 |
|
7 days |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
1 |
1 |
2 |
2.00 |
23 |
F |
Not rinsed |
0 |
0 |
1 |
1 |
2 |
|
24 |
F |
Not rinsed |
0 |
0 |
1 |
1 |
2 |
|
14 days |
||||||||
22 |
M |
Not rinsed |
0 |
0 |
0 |
0 |
0 |
0.00 |
23 |
F |
Not rinsed |
0 |
0 |
0 |
0 |
0 |
|
24 |
F |
Not rinsed |
0 |
0 |
0 |
0 |
0 |
* Positive effect
- Could not be assessed. Strong reaction to treatment may preclude evaluation of some parameters. Therefore the primary irritation score may differ from the mean cumulative score at 24, 48, and 72 hours
M male
F female
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test item did not cause any skin effects in acute dermal irritating studies according to OECD test guideline 404. Therefore, the target substance does not warrant classification for skin irritation. Based on the available data from a suitable in vivo eye irritation studies with the target substance classification for eye irritation Category 2 is warranted.
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.