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EC number: 220-120-9 | CAS number: 2634-33-5
- 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)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed in 1990 before the requirement of LLNA study was mandated.
- Specific details on test material used for the study:
- NBW 8008/71 [7015/16 TIF]
The Test Substance employed was pre-dried technical grade active substance - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Young adults weighing 313-368 g (main study)
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 3% w/v DMF in corn oil
- Concentration / amount:
- Intradermal: A row of three injections (0.05-0.1 mL each) was made on each side of the mid-line. The injections were:
i) Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil in the ratio 1:1;
ii) 0.01% (w/v) preparation of the test sample in 3% w/v DMF in corn oil;
iii) 0.01% (w/v) preparation of the test sample in a 1:1 Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil
Topical: One week later, the scapular area was clipped again and treated with a topical application of the test sample as a 30% (w/v) preparation in DMF. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: 3% w/v DMF in corn oil
- Concentration / amount:
- Induction of the control animals: intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
(i) Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil in the ratio 1:1
(ii) 3% w/v DMF in corn oil only
(iii) Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil in the ratio 1:1
The topical applications followed the same procedure as for the test animals except that DMF only was applied to the filter paper. - Vehicle:
- other: 3% w/v DMF in corn oil
- Concentration / amount:
- 10% (w/v) in DMF
3% (w/v) in DMF - No. of animals per dose:
- 20 test group, 10 negative control group, 20 positive control group
- Details on study design:
- 1st application: Induction 0.01%; intracutaneous
2nd application: Induction 30%; epicutaneous
3rd application: Challenge 10%; epicutaneous - Challenge controls:
- 10% (w/v) in DMF
3% (w/v) in DMF - Positive control substance(s):
- yes
- Positive control results:
- Positive control results: Following challenge with a 50% (w/v) dilution of the 40% (w/v) aqueous formaldehyde solution, scattered mild redness to moderate diffuse redness was seen in fourteen out of the seventeen test animals scored.No response was seen in any of the ten control animals. The net percentage response was calculated to be 82%.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness to intense redness and swelling was seen in thirteen out of twenty test animals.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% w/v
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness was seen in two out of twenty test animals.
- Remarks on result:
- other: Weak sensitizer
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% w/v
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness to intense redness and swelling was seen in thirteen out of twenty test animals.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% w/v
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Scattered mild redness was seen in one out of twenty test animals.
- Remarks on result:
- other: Weak sensitizer
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Conclusions:
Materials and methods
The sensitising properties of the test sample were assessed using a method based on the maximisation test of Magnusson and Kligman (1970).
(a) Induction
The hair was removed from an area approximately 5cm x 5cm on the scapular region of each animal with a pair of veterinary clippers and a row of three injections (0.05-0.l mL each) was made on each side of the mid-line. The injections were:
i) Top: Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil in the ratio 1:1;
ii) Middle: a 0.01% (w/v) preparation of the test sample in 3% w/v DMF in corn oil;
iii) Bottom: a 0.01% (w/v) preparation of the test sample in a 1:1 Freund’s Complete Adjuvant plus 3% w/v DMF in corn oil.
The injections were checked for any adverse effects for up to 48 hours.
One week later, the scapular area was clipped again and treated with a topical application of the test sample as a 30% (w/v) preparation in DMF. This preparation (0.2-0.3 mL) was applied on filter paper held in place by surgical tape. The tape was covered by an occlusive dressing which was kept in place for 48 hours.
The application sites were checked approximately 24 hours after removal of the dressings.
(b) Challenge
Two weeks after the topical inductions, an area, approximately 15cm x 5cm, on both flanks of all the test and control animals, was clipped free of hair with a pair of veterinary clippers. An occlusive dressing was prepared which consisted of two pieces of filter paper stitched to a piece of rubber sheeting.
A 10% (w/v) preparation of the test sample (0.05-0.l mL) in DMF was applied to one of the pieces of filter paper and a 3% (w/v) preparation in DMF (0.05-0.l mL) was applied to the second piece of filter paper. The dressing was placed on to the guinea pig so that the 10% (w/v) preparation was on the left shorn flank and the 3% (w/v) preparation was on the right shorn flank. It was then covered with a strip of adhesive bandage which was secured by a self-adhesive PVC tape.
After twenty four hours, the dressings were removed and discarded.
After a further 24 and 48 hours, any erythematous reactions were quantified and the number of positive responses was recorded.
Results and discussion
Challenge of previously induced guinea pigs with a 10% (w/v) preparation of benzisothiazolin-3-one in DMF elicited a moderate skin sensitisation response and challenge with a 3% (w/v) preparation elicited a mild skin sensitisation response.
Therefore, benzisothiazolin-3-one was a moderate skin sensitiser under the conditions of the test.- Executive summary:
A study was conducted to determine the skin sensitisation potential of the substance according to US EPA Guideline OPP 81-6. The method followed Magnusson and Kligman maximisation protocol closely. The test was performed in 50 (20 test, 10 negative control and 20 positive control) female albino Dunkin Hartley guinea pigs. The intradermal induction of sensitization in the test group was performed in the scapular region with a 0.01% dilution of the test substance in purified water in an emulsion of Freund’s Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 h under occlusion with the test substance at 30% in dimethyl formamide one week after the intradermal induction. The animals of the control group were intradermally induced with DMF under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test substance at 10% in DMF on the left flank and 3% in DMF on the right flank occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. Challenge of previously induced guinea pigs with a 10% (w/v) preparation of the test substance in DMF elicited a moderate skin sensitisation response and challenge with a 3% (w/v) preparation elicited a mild skin sensitisation response. Under the study conditions, the substance was considered to be a moderate skin sensitiser (Botham, 1990).
Reference
24 h after challenge |
High dose (10% w/v): 13/20 Low dose (3% w/v): 2/20 |
48 h after challenge |
High dose (10% w/v): 13/20 Low dose (3% w/v): 1/20 |
Following challenge with a 10% (w/v) preparation of the test sample in DMF, scattered mild redness to intense redness and swelling was seen in thirteen out of twenty test animals.Scattered mild redness was seen in three out of ten control animals. The net percentage response was calculated to be 35%.
Following challenge with a 3% (w/v) preparation of the test sample in DMF, scattered mild redness was seen in two out of twenty test animals. No erythematous response was seen in any of the control animals. The net percentage response was calculated to be 10%.
% net response description
0 not a sensitiser
1-8 weak sensitiser
9-28 mild sensitiser
29-64 moderate sensitiser
65-80 strong sensitiser
81-100 extreme sensitiser
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the substance according to US EPA Guideline OPP 81-6. The method followed Magnusson and Kligman maximisation protocol closely.The test was performed in 50 (20 test, 10 negative control and 20 positive control) female albino Dunkin Hartley guinea pigs. The intradermal induction of sensitization in the test group was performed in the scapular region with a 0.01% dilution of the test substance in purified water in an emulsion of Freund’s Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 h under occlusion with the test substance at 30% in dimethyl formamide one week after the intradermal induction. The animals of the control group were intradermally induced with DMF under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test substance at 10% in DMF on the left flank and 3% in DMF on the right flank occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. Challenge of previously induced guinea pigs with a 10% (w/v) preparation of the test substance in DMF elicited a moderate skin sensitisation response and challenge with a 3% (w/v) preparation elicited a mild skin sensitisation response. Under the study conditions, the substance was considered to be a moderate skin sensitiser (Botham, 1990).
A study was conducted to determine the skin sensitisation potential of the substance in guinea-pigs according to OECD Guideline 406 through the Magnusson-Kligman maximisation protocol. The closely-clipped dorsa of ten male and ten female Dunkin-Hartely guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 1% w/v of the test substance in purified water and 5% w/v of the substance in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 5% w/v of the test substance in purified water and the test site was covered by an occlusive dressing for 48 hours. The same induction procedures were carried out on a contemporaneous control group of five male and five female animals, except that the test substance was replaced by vehicle in all doses. On Day 22, all animals were challenged by occluded application of purified water to the left flank and 3% w/v and 0.5% w/v of the test substance in purified water to two sites on the right flank. Intradermal injection at 1% w/v in purified water and 5% w/v in the adjuvant gave rise to moderate erythema, pallor and discolouration. Occluded topical application at 5% w/v in purified water caused barely perceptible or slight erythema, exfoliation and low incidences of eschar formation or oedema. Challenge application at 3% w/v in purified water gave rise to a significant response (slight erythema or a more marked reaction) in ten test animals. A significant response was observed in four test animals following challenge application of 0.5% w/v of the substance in purified water. Under the study conditions, the substance was considered to be a skin sensitiser in guinea pigs (Rees, 1994).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the in vivo skin sensitisation study results in guinea pigs, the substance warrants classification as Skin sens. 1B ( H317: May cause an allergic skin reaction) according to EU CLP (1272/2008) criteria.
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