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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was carried according to OECD Guideline No. 404 and EEC Directive 84/449/EEC, Part 8.4 and in accordance with the Principles of Good Laboratory Practices (GLP) as the remanants of the test substance could not be removed from the treatment area and the scores were from approximately 25% of the exposed area.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approximately 13 weeks
- Weight at study initiation: 2748 - 3096 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were assessed at approximately 45 minutes, 24, 48 and 72 hours and 7, 14 and 21 days after the removal of the dressings and test substance.
- Number of animals:
- 3 male rabbits
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10 cm x 15 cm).
Prior to test substance administration, the animals were physically examined and the shaved area of skin to be treated was normal.
On test day 1, 0,5 gram of the test substance was applied to the intact skin of the shaved area on one flank, using a Scotchpak non-woven patch (2x3 cm, 3M, St.Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).
Four hours after the application, the dressing was removed and an attempt was made to remove the remaining test substance, using a tissue moistened with tap water and subsequently a dry tissue. However, a brown/yellow sticky layer remained in the treated area.
In order to facilitate the scoring, the skin sites concerned of all animals were reshaved before the observation on days 2, 3, 4, 15 and 22. However, reshaving on days 2, 3 and 4 of the treated skin sites was difficult due to the presence of sticky remnants of’ the test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: rabbit # 3987
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: rabbit # 3988
- Time point:
- other: 24, 48 and 72 hours
- Reversibility:
- other: No data
- Remarks on result:
- not determinable
- Remarks:
- Erythema could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance in the area of application.
- Irritation parameter:
- erythema score
- Basis:
- animal: rabbit # 3989
- Time point:
- other: 24, 48 and 72 hours
- Reversibility:
- other: No data
- Remarks on result:
- not determinable
- Remarks:
- Erythema could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance in the area of application
- Irritation parameter:
- edema score
- Basis:
- animal: rabbit #3987
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: rabbit # 3988
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: rabbit # 3989
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- The test substance could not be removed from the treated skin sites after the 4 hour exposure. The presence of a brown/yellow, sticky layer made scoring of (large parts of) the skin sites impossible for erythema and/or oedema for the first four days of the study. The parts of’ the skin that could be scored, showed no or very slight erythema and very slight or slight oedema. At the observation 7 days after exposure the treated skin sites of all three animals were noted to be bald and showed moderate to severe erytherna and very slight oedema. The sites were covered with a thick layer of scales, mixed with remnants of the test substance. The skin irritation had resolved within 14 days after exposure in animals 3987 and 3988. Slight skin irritation and scaliness persisted in animal 3989 at the 14-day and 21-day observations. The treated skin of all three animals was still noted to be bald at the final observation.
There was no evidence of a corrosive effect on the skin. - Other effects:
- A brown/yellow sticky layer of remnants of the test substance could not be removed from the treated area after the 4 hour exposure period and was also noted at the observations on days 1 to 4 in all three animals. Brown/yellow remnants of the test substance were still noted in the treated area on day 8 in all three animals and on days 15 and 22 in animal 3989.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual scores
24 hours-
Rabbit | Erythema | Edema | Comments |
3987 | 0 | 2 | Approx. 75% of the treated area could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance. |
3988 | - | 1 | Oedema could be scored for approx. 25% of the treated area. Scoring of the remaining area was impossible due to the presence of remnants of the test substance. |
3899 | - | 1 | same as above |
- Erythema could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance in the area of’ application.
48- hours-
Rabbit | Erythema | Edema | Comments |
3987 | 0 | 1 | Approx. 75% of the treated area could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance. |
3988 | - | 1 | In animals 3988 and 3989, oedema could be scored forapprox. 25% of the treated area. Scoring of the remaining area was impossible due to the presence of remnants of the test substance. |
3899 | - | 1 | same as above |
- Erythema could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance in the area of’ application.
72 -hours-
Rabbit | Erythema | Edema | Comments |
3987 | 0 | 1 | In all three animals, both erythenia and oederna could be scored for approx. 25% of the treated area. Scoring of the remaining area was impossible due to the presence or a brown/yellow, sticky layer of remnants of the test substance. |
3988 | 1 | 2 | same as above |
3899 | 1 | 2 | same as above |
- Erythema could not be scored due to the presence of a brown/yellow, sticky layer of remnants of the test substance in the area of’ application.
7 days-
Rabbit | Erythema | Edema | Comments |
3987 | 3 | 1 | In all three animals a thick layer of scales, mixed with brown/yellow remnants of the test substance, was seen in the area of application. Underneath, a bald skin with erythema score 3 was observed. |
3988 | 3 | 1 | same as above |
3899 | 3 | 1 | same as above |
14 days-
Rabbit | Erythema | Edema | Comments |
3987 | 0 | 0 | In all three animals, approx. 80% of’ the treated skin was noted to be bald. Scaliness, mixed with orange/yellow remnants of the test substance, was noted in approx. 50% of the treated area of animal 3989. |
3988 | 0 | 0 | same as above |
3899 | 0 | 1 | same as above |
21 days-
Rabbit | Erythema | Edema | Comments |
3987 | 0 | 0 | In all three animals, approx. 80% of the treated skin was noted to be bald. In animal 3989, the bald skin showed erythema score 1 and scaliness, mixed with orange/yellow remnants of’ the test substance, was noted at the edges of the treated area. |
3988 | 0 | 0 | same as above |
3899 | 1 | 2 | same as above |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Using the available scores a primary irritation index of 1.8 was calculated, indicating that MORTRACE SB CONC. was mildly irritating to the rabbit skin. However, the appearance of a bald skin, moderate to severe erythema and scaliness 7 days after exposure indicate that the scores obtained at the 24 to 72 hour observations were probably an underestimation of the irritating potential. Therefore, for the purpose of safety evaluation, NORTRACE SB CDNC. was considered moderately irritating.
- Executive summary:
The purpose of this study was to assess the possible skin irritation or skin corrosion potential of MORTRACE SB CONC. in rabbits.
This study was carried out in accordance with DECO Guideline No. 404, “Acute Dermal Irritation / Corrosion” and EEC Directive 84/449/EEC, Part 8.4, “Acute Toxicity - Skin Irritation”.
MORTRACE SB CONC. was applied onto shaved skin of three male albino rabbits using semi-occlusive dressings for 4 hours, followed by seven observations at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after removal of the dressings and remaining test substance.
The test substance could not be removed from the treated skin sites and made scoring impossible and/or difficult during the first four days of the study. The parts of the skin that could be scored, showed only slight irritation. 7 Days after exposure a bald skin, scaliness and moderate to severe erythema and very slight oedema were noted in all three animals. The skin irritation had resolved within 14 days after exposure in two animals and slight skin irritation and scaliness persisted in one animal untill termination (day 22). There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
A primary irritation index of 1.8, calculated using the available scores, indicate that MORTRACE SB CONe, was mildly irritating to the rabbit skin. However, based on the clinical signs noted from day 7 onwards the test substance was considered moderately irritating, for the purpose of safety evaluation.
Due to the absence of critical scores, classification of MORTRACE SB CONC. in accordance 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 EEC Directive 67/548/EEC) was difficult. The clinical signs observed from day 7 onwards indicated an irritating potential of the test substance when applied to the rabbit skin. Therefore it was considered that MORTRACE SB CONC. should be labelled as a skin irritant.
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