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EC number: 410-610-2 | CAS number: 111850-24-9 MORTRACE SB CONC.
- 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:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD TG 405 and EEC Directive 84/449/EEC Part B.5 and in accordance with the Principles of Good Laboratory Practices (GLP)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- MORTRACE SB CONC.
- IUPAC Name:
- MORTRACE SB CONC.
- Reference substance name:
- 4-(4-Nitrophenylazo)-2,6-di- sec.butylphenol
- IUPAC Name:
- 4-(4-Nitrophenylazo)-2,6-di- sec.butylphenol
- Reference substance name:
- 4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
- EC Number:
- 410-610-2
- EC Name:
- 4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
- Cas Number:
- 111850-24-9
- Molecular formula:
- C20 H25 N3 O3
- IUPAC Name:
- 2,6-bis(butan-2-yl)-4-[2-(4-nitrophenyl)diazen-1-yl]phenol
- Test material form:
- other: dark red-brown liquid
- Details on test material:
- - Name of test material (as cited in study report): Mortrace SB Conc.
- Physical state: dark red-brown liquid
- Analytical purity: concentrate
- Lot/batch No.: MR 26592 SBC
- Expiry date: June 03, 1993
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature protected from light
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approximately 14-18 weeks
- Weight at study initiation: 3003 grams - 3325 grams
- Housing: individually housed
- Diet: standard rabbit pelleted diet provided approximately 100 grams/day
- Water: ad libitum
- Acclimation period: at least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 ± 2 mg/animal
- Duration of treatment / exposure:
- as per guideline
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 and 14 days after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- Prior to test substance administration, each of the animals were physically examined and the eyes were found to be normal.
The test substance (100 ± 0.2 mg per animal) was instilled in the conjunctival sac of the left eye of one animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about ten seconds to prevent loss of the test substance. The other eye remained untreated and served as the reference control
Immediately after 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively
determine corneal epithelial damage. This procedure was repeated in on day 4, until recovery was completed. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
The two other animals were treated in a similar manner one week later, after considering the degree of eye irritation observed in the first animal. Treatment of the eyes with a fluorescein solution was performed immediately after the observations on days 2, 4 and/or day 8 in these animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal: rabbit 3972
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal: rabbit 3979
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal: rabbit 4011
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal: rabbit 3972
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal: rabbit 3979
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal: rabbit 4011
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal: rabbit 3972
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal: rabbit 3979
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal: rabbit 4011
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal: rabbit 3972
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal: rabbit 3979
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal: rabbit 4011
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour after instillation of MORTRACE SB CONC. into one eye of each of the three male albino rabbits resulted in slight redness and moderate to severe swelling in the conjunctivae. Increase of the conjunctival redness was noted at the 24-hour observation, whereas iridic irritation and slight dulling of normal lustre in the cornea (in two animals only) were also observed. Corneal epithelial damage, determined by fluorescein, was seen on day 2 in all three animals and persisted on day 4 in animal 4011. The corneal damage and iridic irritation had resolved within 48 hours after instillation in animals 3972 and 3979 and within 7 days in animal 4011. The irritation of the conjunctivae had resolved within 14 days in all three animals.
There was no evidence of ocular corrosion. - Other effects:
- The outside of the eyelids were covered with a brown, sticky layer of test substance during the study period. The layer had disappeared at the 14-day observation and a yellow staining of the eyelids remained. No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual Scores
Cornea opacity | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
3972 | 0 | 0 | 0 | 0.0 | 0.0 |
3979 | 0 | 0 | 0 | 0.0 | |
4011 | 0 | 0 | 0 | 0.0 | |
Iris lesion | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
3972 | 1 | 0 | 0 | 0.3 | 0.6 |
3979 | 1 | 0 | 0 | 0.3 | |
4011 | 1 | 1 | 1 | 1.0 | |
Conjunctivae (redness) | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
3972 | 3 | 3 | 2 | 2.7 | 2.8 |
3979 | 3 | 3 | 3 | 3.0 | |
4011 | 2 | 3 | 3 | 2.7 | |
Conjunctivae (chemosis) | |||||
Animal | Observation time | Mean value | Mean value (over all animals) | ||
24 hours | 48 hours | 72 hours | |||
3972 | 1 | 1 | 1 | 1.0 | 1.2 |
3979 | 2 | 1 | 1 | 1.3 | |
4011 | 2 | 1 | 1 | 1.3 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- MORTRACE SB CONC. was considered mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the calculated maximum Draize score: 12.3). According to the EEC criteria for general classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the Directive 67/548/EEC), MORTRACE SB CONC. should be labelled as an eye irritant.
- Executive summary:
The purpose of this study was to assess the possible irritation or corrosion potential when a single dose of MORTRACE SB CONC. was placed in the conjunctival sac of a rabbit eye.
This study was carried out in accordance with OECD Guideline No. 405, “Acute Eye Irritation / Corrosion” and EEC Directive 84/449/EEC, Part 8.5, “Acute Toxicity — Eye Irritation”.
MORTRACE SB CONC. was instilled into one eye of each of three male albino rabbits, followed by six observations at approximately 1, 24, 48 and 72 hours and 7 and 14 days after test substance administration.
Under the conditions of this study, MORTRACE SB CONC. resulted in adverse effects on the cornea, iris and the conjunctivae. Corrieal epithelial damage was observed in all three animals, which resulted in slight dulling of normal lustre in two animals. The corneal damage had resolved within 2 or 7 days. The iridic irritation had resolved within 2-7 days and the irritation of the conjunctivae had resolved within 14 days after instillation in the animals. Ocular corrosion was not observed in any of the rabbits.
Brown, sticky remnants of and yellow staining by the test substance were noted on the outside of the eyelids during the study period.
No signs of systemic intoxication were observed during the study period.
MORTRACE SB CONC. was considered mildly irritating (N2) to the rabbit eye (Kay and Calancira interpretation of the calculated maximum Draize score: 12.3). According to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Council Directive 67/548/EEC), NORTRACE SB CONC. should be labelled as an eye irritant.
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