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EC number: 204-310-9 | CAS number: 119-27-7
- 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:
- October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4-dinitroanisole
- EC Number:
- 204-310-9
- EC Name:
- 2,4-dinitroanisole
- Cas Number:
- 119-27-7
- Molecular formula:
- C7H6N2O5
- IUPAC Name:
- 2,4-dinitroanisole
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: none provided
- Expiration date of the lot/batch: non provided
- Physical Appearance: light yellow powder
- Storage condition of test material: stored at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Male/ female -- ~16 weeks
- Weight at study initiation: Male/ female -- 3.4 - 3.6kg/ ~3.3kg
- Housing: suspended stainless stell cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 48 - 55
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light):12/ 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0790g (or 0.1mL) - Duration of treatment / exposure:
- 15s
- Duration of post- treatment incubation (in vitro):
- 72h
- Number of animals or in vitro replicates:
- 3 (2 males and a female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 15s
- Observation: 1, 24, 48 and 72 h
- Mortality observation: done twice daily (morning and afternoon)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Ocular Observations Individual Data: Table 1
Obervations were based onthe Ocular Grading System presented which is based on Draize (1959)
Exposure to the test article produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours. Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval. The conjunctiva! irritation resolved completely in all test eyes by 48 hours. An additional ocular finding included test article present in the eye which was noted in 3/3 test eyes.
No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
Any other information on results incl. tables
Table 1 A Primary Eye Irritation Study in Rabbits, INDIVIDUAL OCULAR IRRITATIONSCORES (NO RINSE GROUP)
Animal No./Sex |
|
|
|
Test Eye |
|
|
Control Eye |
||||||||
Body Weight |
Scoring |
Cornea |
Iris_ |
Conjunctivae |
S econdary |
|
|||||||||
(kg) |
Interval |
0 |
A |
OxAx5 |
I |
lx5 |
R |
S |
D |
(R+S+D)*2 |
Total |
Fluorescein Examination |
Secondary Ocular Findings |
Fluorescein Examination |
Secondary Ocular Findings |
R3014/M |
1 Hour |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
8 |
8 |
|
TAE |
|
|
3.363 |
24 Hours |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
[-] |
|
[-] |
|
|
48 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
72 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
R3009/M |
1 Hour |
0 |
0 |
0 |
1 |
5 |
2 |
2 |
1 |
10 |
15 |
|
TAE |
|
|
3.611 |
24 Hours |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
[-] |
|
[-] |
|
|
48 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
72 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
R3042/F |
1 Hour |
0 |
0 |
0 |
1 |
5 |
2 |
1 |
1 |
8 |
13 |
|
TAE |
|
|
3.254 |
24 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
[-] |
|
[-] |
|
|
48 Hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
72 Hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean Ocular Scores
1 Hour |
12.00 |
24 Hours |
1.33 |
48 Hours |
0 00 |
72 Hours |
0.00 |
Table 2 OCULAR EVALUATION CRITERIA
Maximum mean score (days 0-3) |
Maximum mean score |
Persistence of Individual Scores |
Descriptive Rating and Class |
||
0.00 - 0.49 |
24 hours= 0 |
|
Non-lrritating |
1 |
|
24 hours> 0 |
|
Practically Non-lrritating |
2 |
||
0.50 - 2.49 |
24 hours= 0 |
|
Non-lrritating |
1 |
|
24 hours> 0 |
|
Practically Non-lrritating |
2 |
||
2.50 - 14.99 |
48 hours= 0 |
|
Sliqht Irritant |
3 |
|
48 hours> 0 |
|
Mild Irritant |
4 |
||
15.00 - 24.99 |
72 hours= 0 |
|
Mild Irritant |
4 |
|
72 hours> 0 |
|
Moderate Irritant |
5 |
||
25.00 - 49.99 |
7 days 20 |
> half of day 7 scores |
s 10 |
Moderate Irritant |
5 |
" · > half of day 7 scores but no score >20 |
> 10, |
Moderate Irritant |
5 |
||
> half of day 7 scores and any score > 20 |
> 10, |
Severe Irritant |
6 |
||
7 day> 20 |
|
Severe Irritant |
6 |
||
50.00 - 79.99 |
7 days 40 |
> half of day 7 scores |
s 30 |
Severe Irritant |
6 |
> half of day 7 scores but no score > 60 |
> 30, |
Severe Irritant |
6 |
||
> half of day 7 scores and any score > 60 |
> 30, |
Very Severe Irritant |
7 |
||
7 day> 40 |
|
Very Severe Irritant |
7 |
||
80.00 - 99.99 |
7 days 80 |
> half of day 7 scores |
s 60 |
Very Severe Irritant |
7 |
> half of day 7 scores but no score > 100 |
> 60, |
Very Severe Irritant |
7 |
||
> half of day 7 scores and any score > 100 |
>60, |
Extremely Severe Irritant 8 |
|||
7 day> 80 |
|
Extremely Severe Irritant 8 |
|||
100.00 - 110.00 |
7 days 80 |
|
Very Severe Irritant |
7 |
|
7 day> 80 |
|
Extremely Severe Irritant 8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the no rinse group, test item is considered to be slightly irritant to the ocular tissue of the rabbit.
Expose to the test item produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours.
Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval.
The conjunctival irritation resolved completely in all tests eyes by 48 hours.
An additional ocular finding included test item present in the eye which was noted in 3/3 test eyes.
No corneal opacity, iritis or conjunctivitis observed in the control eyes - Executive summary:
The potential irritant and/or corrosive effects of 2,4 Dinitroanisole were evaluated on the eyes of New Zealand White rabbits. Each of three rabbits received a 0.0790 g (0.1 ml weight equivalent) dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing.
Exposure to the test article produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours. Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by 48 hours. An additional ocular finding included test article present in the eye which was noted in 3/3 test eyes.
Based on the no rinse group, 2,4-Dinitroanisole is considered to be a slight irritant to the ocular tissue of the rabbit, but not sufficient for classification under CLP regulation.
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