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Diss Factsheets
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EC number: 220-239-6 | CAS number: 2682-20-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 June - 16 July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP/Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA 40 CFR Part 158; Guideline 81-3
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. D.O.T. Section 173.137
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Test material form:
- other: brown solid
- Details on test material:
- The test substance, identified as RH-573 Technical (Lot No. SW 1029), was assigned Rohm and Haas Toxicology Department Sample No. 95-100. RH-573 Technical was a brown solid containing 97.8% 2-methyl-4-isothiazolin-3-one as the active ingredient.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Adult male New Zealand White rabbits were obtained from Hazleton Research Animals, Denver, PA. Upon arrival, all animals were examined for physical abnormalities, identified by uniquely numbered ear tags, and quarantined for approximately two weeks. The animals were individually housed in stainless steel cages (18 x24x14 in., i.e. 46x61x 37 cm) suspended above absorbent-paper pan liners which were changed 3 times per week. Throughout the test period, all rabbits had free access to filtered tap water (via automatic watering) and were fed approximately 125 g/day of PMI Certified High Fiber Rabbit Diet 5325 (Purina Mills Inc., Richmond, IN). All animal rooms were environmentally controlled with controls set to maintain a temperature of approximately 65°F (18°C) and a relative humidity range of 30-70%. The temperature and relative humidity were monitored 24 hrs a day. During the study, the average daily temperature ranged from 65 to 66°F (18 to 19°C) and average daily humidity ranged from 55 to 66%. Excursions beyond these ranges were minimal and did not affect the integrity of the study. Temperature and humidity remained in compliance with acceptable ranges defined in the "Guide for the Care and Use of Laboratory Animals" NIH Publication No. 86-23, Revised 1996. The light cycle was automatically controlled, 12 hrs on and 12 hrs off.
One day prior to dosing, rabbits were selected from a healthy stock population. At the time they were dosed, the animals were approximately 20 to 25 weeks old and their body weights ranged from 2868 to 3136 g.
Test system
- Type of coverage:
- other: Semiocclusive for 1 and 4 hour exposure and open for 3 minute exposure.
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- The solid test substance was heated to approximately 60°C (the test substance was allowed to cool at room temperature prior to dosing) and applied
(0.5 ml) onto a 1.0-in. square gauze-lined adhesive bandage which was applied to the shaved intact skin of one rabbit. - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, 48, 72 hrs and at 7 and/or 14 days after patch removal.
- Number of animals:
- 1 animal each for 1 and 4 hour exposures and 6 rabbits for 3 minute exposure
- Details on study design:
- Approximately 24 hrs prior to the application of the test substance, the hair around the entire trunk between the flank and shoulders was shaved closely with electric clippers. The solid test substance was heated to approximately 60°C (the test substance was allowed to cool at room temperature prior to dosing) and applied (0.5 ml) onto a 1.0-in. square gauze-lined adhesive bandage which was applied to the shaved intact skin of one rabbit for 4 hrs. A semi-occluded dressing (i.e., fabric cuff secured with adhesive tape) was used to wrap the entire trunk of the animal. The rabbit was returned to its cage for a 4 hr exposure period. An additional rabbit was tested on two separate sites for a 1 hr (right side) and 3 minute (left side) exposure. The 1 hr site was treated in the same manner as the 4 hr. The animal remained uncuffed during the 3 minute exposure. Five additional rabbits were tested for 3 minute exposures to complete DOT testing requirements. The cuff and patch were removed after the appropriate exposure and the application site wiped with paper towels saturated with tap water. The application site was blotted dry with paper towels.
Observations and Determinations
Skin irritation was evaluated at approximately 1, 24, 48, 72 hrs and at 7 andlor 14 days after patch removal. The degree of irritation was evaluated
according to the criteria of Draize et al. (J. Pharmacol. Exp. Therap. 82, 377-390, 1944). In addition, all other skin reactions or signs of systemic toxicity were recorded. Animals were observed daily for mortality and reaction to treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- On the 4 and 1 hr sites, skin irritation indicative of corrositivity (i.e., concave eschar) was observed on day 14 and day 7, respectively. On the 4 hr exposure site, severe erythema was evident at all observation periods. Severe edema was noted up to and including day 7, but was no longer evident on day 14. On the 1 hr site, severe erythema was observed at all observation periods and severe edema was noted up to and including 72 hrs. Edema was no longer evident on day 7.
On the 3 minute site, very slight to well defined erythema was noted up to and including 24 hrs (all rabbits), at 48 hrs (4 rabbits), at 72 hrs (2 rabbits) and very
slight erythema (2 rabbits) was still evident on day 7. Very slight to moderate edema was noted at 1 hr (all rabbits) and at 24 hrs (2 rabbits). Very slight to slight
edema was noted in one rabbit at 48 and 72 hrs. Edema was no longer evident on day 7. - Other effects:
- No mortality or clinical signs of systemic toxicity (other than skin effects) were observed during the study.
Any other information on results incl. tables
No additional information available.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- According to the Rohm and Haas Company Acute Toxicity and Irritation Hazard Categories (September, 1994), RH-573 Technical is categorized as CORROSIVE to skin following a 4 hr exposure period (i.e., evidence of irreversible destruction of dermal tissue).
According to DOT Packing Group Classification guidelines for Class 8 material (June, 1990), RH-573 Technical is assigned to PACKING GROUP II (i.e., corrosive at the site of contact when tested on the intact skin of rabbits for a period of greater than 3 minutes but not more than 1 hr). - Executive summary:
Skin irritation of RH-573 Technical (Lot No. SW 1029, Toxicology Department Sample No. 95-100, 97.8% active ingredient) was assessed in New Zealand White rabbits. The solid test substance was heated to approximately 60°C (the test substance was allowed to cool at room temperature prior to dosing) and applied topically (0.5 ml) to the shaved intact skin of one male rabbit. The application site was semi-occluded for 4 hrs. After the 4 hr exposure, the application site was wiped with paper towels saturated with tap water and blotted dry with paper towels. Skin irritation was evaluated according to Draize criteria at approximately 1, 24, 48, 72 hrs and 7 days and 14 days after patch removal. No mortality or clinical signs of systemic toxicity were observed during the study. Skin irritation indicative of corrositivity (i.e., concave eschar) was observed. According to the Rohm and Haas Company Acute Toxicity and Irritation Hazard Categories (September, 1994), RH- 573 Technical is categorized as CORROSIVE to skin (i.e., evidence of irreversible destruction of dermal tissue).
Since corrosive findings were evident at 4 hrs, additional rabbits were tested to determine U.S. Department of Transportation (DOT) Packing Group classification. The solid test substance was heated to approximately 60°C (the test substance was allowed to cool at room temperature prior to dosing) and applied topically for 1 hr (0.5 ml, right side) and for 3 minutes (0.5 ml, left side) to the shaved intact skin of one male rabbit. The 1 hr application site was semi-occluded with a fabric cuff and the 3 minute site was uncuffed during the exposure period. After each exposure period, the application sites were wiped with paper towels saturated with tap water and blotted dry with paper towels. Skin irritation was evaluated according to Draize criteria at approximately 1, 24, 48, 72 hrs and 7 days after patch removal. Skin irritation indicative of corrositivity (i.e., concave eschar) was observed on the 1 hr site. On the 3 minute site, very slight to well defined erythema was noted through day 7 and slight edema was noted at 1 hr. An additional 5 rabbits were subjected to a 3 minute exposure (in the same manner as above) to complete DOT testing. Very slight to well defined erythema was noted through 48 hrs in most rabbits. Very slight to moderate edema was noted at 1 and 24 hrs. Very slight to slight edema was noted in one rabbit at 48 and 72 hrs. According to DOT Packing Group Classification guidelines for Class 8 material (June, 1990), RH-573 Technical is assigned to PACKING GROUP II (i.e., corrosive at the site of contact when tested on the intact skin of rabbits for a period of greater than 3 minutes but not more than 1 hr).
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.
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