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EC number: 230-989-6 | CAS number: 7394-38-9
- 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:
- May 03 - June 14, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2nd October 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- EC Number:
- 230-989-6
- EC Name:
- p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- Cas Number:
- 7394-38-9
- Molecular formula:
- C7 H5 N O4 . C6 H15 N O3
- IUPAC Name:
- p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Lot no. 2601LP2609
Storage: At room temperature, protected from light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: S & K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
Hygienic level during the study: good conventional
Justification of strain: The New Zealand white rabbit is one of the standard animals in acute eye irritation study.
Number of animal: 3 males
Age of animals: adult rabbits, 12 weeks old
Body weight range at the beginning of the study: 2560 - 2618 g
Body weight range at the end of the study: 2850 - 2898 g
Date of receipt: April 28, 2017
Acclimatisation time: 5 days in first animal, 6 days in second animal and 7 days in third animal
Animal health: Only animals in acceptable health condition were used for the test.
Room: 11/C
Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: above 10 air exchanges/hour by central air-condition system
The environmental parameters were recorded daily during the study.
Food: The animals received S&K LAP rabbit diet produced by Cargill Takarmány Zrt., 5300 Karcag, Madarasi út 0399. Hungary, ad libitum.
Water supply: Animals received tap water from watering bottles ad libitum.
The drinking water is periodically analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Identification: Individual animal identification of the rabbits was performed by numbered ear tag.
The cages were marked with individual identity cards with information about study number, test item, sex, strain, dose group, date of arriving of animals, room number, cage number and individual animal numbers.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1g of the test item was used.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
Any clinical signs of toxicity or signs of pain and/or distress were recorded at least twice daily, with a minimum of 6 hours between observations. - Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The eye irritation scores were evaluated according to the scoring system by Draize (1979) and OECD 405 (02 October 2012) presented by the following table.
1. Conjunctivae
A. Redness (Palpebral and bulbar)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
B.Chemosis
Normal 0
Some swelling above normal (includes nictating membrane) 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
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, on considerable area
around the eye 3
2. Iris
D. Values
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia: or injection: iris reactive to light
(a sluggish reaction is considered to be an effect) 1
Hemorrhage, gross destruction, or no reaction to light. 2
3. Cornea
E. 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
F. Area of cornea involved
One quarter (or less), but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0.66 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: one week
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application.
One hour after treatment some hyperemic blood vessels (score 1) were observed and the swelling of the conjunctivae was different from normal (score 1) in all animals. The amount of discharge of the conjunctivae was different from normal (score 1) in all animals.
24 hours after treatment some hyperemic blood vessels (score 1) were observed in all animals. The swelling and the amount of discharge of the conjunctivae was different from normal (score 1) in animal No.: 933.
48 hours after treatment some hyperemic blood vessels (score 1) were observed in all animals. The amount of discharge of the conjunctivae was different from normal (score 1) in animal No.: 933.
72 hours after treatment some hyperemic blood vessels (score 1) were observed in two animals (No.: 931, 933). Animal No.: 932 became free of symptoms.
1 week after treatment all animals were free of symptoms.
1 week after the treatment the study was finished.
During the study the control eyes of animals were symptom-free.
Any other information on results incl. tables
Individual scores for ocular irritation
Study no: 805-405-2611 Species: NZW Rabbit
Dose: 0.1 g Sex: Male
Test Item: p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1)
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
1 hour after the treatment |
932 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
- |
931 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
- |
|
933 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
- |
24 hour after the treatment |
932 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
931 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
933 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
- |
48 hour after the treatment |
932 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
931 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
933 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
72 hour after the treatment |
932 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
931 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
933 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
1 week after the treatment |
932 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
931 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
933 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Abbreviations: R = Redness OD = Opacity degree of density
CH = Chemosis OE = Extension of opaque area
D = Discharge
Mean values of eye irritation scores for EU classificatio
(24, 48 and 72 hours reading)
Study no: 805-405-2611 Species: NZW Rabbit
Dose: 0.1 g Sex: Male
Test Item: p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1)
Animal |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
932 |
male |
0.00 |
0.00 |
0.66 |
0.00 |
0.00 |
931 |
male |
0.00 |
0.00 |
1.00 |
0.00 |
0.00 |
933 |
male |
0.00 |
0.00 |
1.00 |
0.33 |
0.66 |
Body weight data
Animal Number |
Beginning of study |
At the end of study |
Body weight gain |
932 |
2560 |
2898 |
338 |
931 |
2618 |
2898 |
280 |
933 |
2572 |
2850 |
278 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, test item p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which were fully reversible within 1 week.
- Executive summary:
The acute eye irritation study with test itemp-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1)was performed in New Zealand White rabbits. The irritation effect of the test item was scoring according to the Draize method (Draize, 1959; OECD Guideline 405, 2012).The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eye served as control. 0.1 g of the test item was used for the study in a single dose. The test material was ground to a fine dust. The eyes of the test animals were not washed out.Treated and control eyes were examined at 1, 24, 48 and 72 hours the 1 week after the application.1 hour after the single application of test item into the eye of the rabbits, slight redness, chemosis and discharge occurred in all animals. 72 hours after the treatment slight rednesswas observed in two animals. One animal became free of symptoms. 1 week after the treatment all animals were free of symptoms, so the study was terminated. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00
redness : 0.66, 1.00, 1.00
chemosis : 0.00, 0.00, 0.33
discharge : 0.00, 0.00, 0.66
No systemic toxicity was observed on the day of the treatment and during the 1-week observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in animals between the treatment day and at first observation of Day 2.
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