Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 680-227-5 | CAS number: 71449-78-0
- 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
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation: Category 1A for skin sensitisation; OECD 406- GPMT. P.A.M. Daamen. 1988
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:
- 13 September 1988 - 14 October 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted to international guideline although the test item purity was not disclosed.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In accordance with REACH Regulation (EC) 1907/2006: Annex VII: column 2 as amended by Commission Regulation (EU) 2017/706, a well documented study report conducted before 10 May 2017, following a method equivalent or similar to guideline with acceptable deviations is available. This is sufficient to fulfil the standard information requirement in accordance with REACH Regulation (EC) 1907/2006: Annex XI: section 1.1.2 since adequate and reliable (with restrictions) study information has been provided suitable for classification and labelling and/or risk assessment.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, FRG.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: Not reported
- Age at study initiation: approximately 8 weeks at study initiation
- Weight at study initiation: 335 - 476 g.
- Housing: 2 animals per cage metal cages with wire-mesh floor
- Diet (e.g. ad libitum): standard diet including ascorbic acid (1600 mg/kg) in addition hay was provided once a week.
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least 7 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21ºC
- Humidity (%): 45- 75 %
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12 h: 12 h (light: dark)
- IN-LIFE DATES: Not reported - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction phase
The animals received intradermal injection of 0.1 ml of test item (5% and 10 % w/w in propylene glycol).
Followed topical exposure to 0.5 ml of 50% (w/w in propylene glycol - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.05 ml of the test item at concentration on 50%, 25%, 10% & 0% (w/w) held in place for 24hours
- No. of animals per dose:
- 20 Treated animals
10 control animals - Details on study design:
- Test methods:
The animals were allocated to two groups; one experimental group go 20 animals and one group of 10 animals representing the control groups.
The remaining animals were used for primary irritation experiments. the main study comprised two phases: induction and challenge.
Primary irritation experiments:
Primary irritation experiment included intracutaneous injections and epicutaneous application of several concentrations of the test substance diluted in propylene glycol (OPG, Utrecht, the Netherlands). For animals received epicutaneous applications of the test substance at 50%, 25%, 10% and 5 % (w/w) in amount of 0.05 ml using square chamber (v.d. Bend, Brielle, The Netherlands). The skin reactions of these four animals are summarised. One animal received 4 x 0.1 ml intracutaneous injections of 5% (w/w) and 0.5 ml 50% (w/w) test substance epicutaneously applied.
Induction Phase:
Day 0, Control Group.
the fur from an approximately 4 cm x 6 cm between the shoulders was removed by clipping. Three pairs of intradermal injections were made in such a way that the three injections formed a row on each sides of the midline. The six injections were made within the boundaries of 2 cm x 4 cm area, over which a patch was applied one week later, the injections consisted of:
A. 0.1 ml vehicle alone: propylene glycol (OPG, Utrecht, the Netherlands).
B. 0.1 ml Freunds Complete Adjuvant (FCA, DIFCO, Detroit, USA) emulsified with an equal volume of distilled water (Pyrogen free, Ferensius AG, Bad Homburg, FRG).
C. 0.1 ml FCA, emulsified with equal volume of propylene glycol.
The injections A & B are made close to each other and most cranial, the injection C were made caudal to Injections A & B.
Day 0, Experimental group.
These animals received the same treatment as the control; groups., but the injections consisted of:
A. 0.1 ml of the test substance (5% w/w in propylene glycol).
B. 0.1 ml of FCA emulsified with an equal volume of distilled water
C. 0.1 ml of the test substance (10% w/w in propylene glycol) emulsified with equal volume of FCA.
Day 6, Control group and Experimental group.
the skin of the shoulder area was treated with sodium dodecyl sulfate (Merck, Darmstadt, FRG), 10% in petrolatum (Ph. Ned, Brocacef, Maarssen, The Netherlands).
Day 7, Control Group. The same area in the shoulder region was clipped. A patch of Metalline (Lohamann, Neuwid FRG) (2 cm x 4 cm), moistened with 0.5 ml propylene glycol, was fixed onto a strip of micropore-tape (3M co., St. Paul, USA) which was applied to the shoulder skin over the injection sites and secured by an elastic bandage (Caban, 3M Co., St. Paul, USA). After 48 hours, the dressings were removed and the treated skin scored according to the scoring system used in the primary irritation experiment.
Day 7, Experimental group.
These animals were exposed and score in a similar manner to the controls, to approximately 0.5 ml of the 50% (w/w, in propylene glycol) test substance concentration.
Challenge Phase.
The challenge
phase was carried out on day 21. In both groups the left flank was shaved. The test substance, diluted in propylene glycol, was applied in an amount of 0.05 ml on square chamber (v.d. Bend, Brielle, The Netherlands), mounted on micropore -tape. Each animal received 4 different concentration go the test substance; all animals were treated similarly. The concentration tested were; 50%, 25%, 10%, and 5% (w/w). The elastic bandage (Coban) was kept in the place for 24 hours. Twenty-four and forty-eight hours after removal of the dressing the reading were made. For proper evaluation of the skin reactions, the treated side was closely shaved on day 23 after the first reading.
Observation:
The challenge application sites of both test and control animals were assessed for skin reactions, which were recorded according to the following
No skin reaction ………………………………….0
Red spots (Scattered reactions) …………….1
Moderated but confluent reactions……..2
Redness and swelling ………………………….3
Intense reddening and swelling ……………4
Any observed signs of general toxicity and local effects other than those indicated above were recorded. Moderate but confluent redness (grad 2) was considered a positive response to the challenge, provided that such a reaction was not observed in the control group.
Interpretation of results:
The readings after application of the challenge dose on day 21 were compared to assess the sensitisation rate i.e. the number of sensitised animals in proportion of the total number of animals in the experimental groups. The sensitisation rate was compared with the Classification of Kligman - Challenge controls:
- 10 animals treated with sodium dodecyl sulfate 10% in petrolatum
- Positive control substance(s):
- no
- Positive control results:
- A previous positive control experiment was conducted in Sep 1987 (NOTOX 0000/809) in order to validate the animals and test procedure.
Test substance: Formaldehyde solution 37% (p.a. art. 4003, Merck, Darmtadt, FRG)
Induction phase: 5% (v/v) in milli-ro water
Challenge phase: 5 %, 3% & 0.5% (v/v) in milli-ro water
A sensitisation rate of 100% was obtained to the 5%, 3% & 0.5% concentrations. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: not reported
- Group:
- positive control
- Dose level:
- 5%, 3% and 0.5%
- Remarks on result:
- other: It is reported that a sensitisation rate of 100% was obtained for the 5%, 3% and 0.5% concentrations
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was considered to be a moderate sensitiser Category 1A.
- Executive summary:
A study in compliance with OECD 406 (1988) was conducted to assess the sensitising potential of the test substance in female guinea pigs of the Dunkin-Hartley strains. One experimental group of 20 animals and one control group of 10 animals were used. The remaining animals were used in the primarily irritation experiments where four animals received an epicutaneous application of the test item in propylene glycol at 50, 25, 10 & 5 % (w/w) in an amount of 0.05ml and one animal received 4 x 0.1 ml intracutaneous injections of 5% (w/w) test item and 0.5 ml 50% (w/w) test item epicutaneously applied. No signs of skin irritation or systemic toxicity was observed in all four animals.
Induction phase: fur from appropriately 4 cm * 6 cm between the shoulders were removed by clipping. Six injections were made over a 2 cm * 4 cm area, for control groups, 0.1 ml of vehicle alone, 0.1 ml Freunds complete Adjuvant (FCA) emulsified with an equal volume of distilled water and 0.1 ml FCA emulsified with an equal volume of propylene glycol. Experimental groups received 0.1 ml test item (5% w/w in propylene glycol), 0.1 ml of Freunds complete Adjuvant (FCA) emulsified with an equal volume of distilled water and 0.1 test item in (10% w/w in propylene glycol) emulsified with equal volume of FCA. The injection sites were covered with patch a week later.
On day 7: Control groups received 0.5 ml of vehicle over the injected sites under occlusive condition for 48 hours. While the experimental group received 0.5 ml of the 50% (w/w in propylene glycol) under occlusive conditions for 48 hours.
Challenge Phase: on day 21, 0.05 ml of the test item at concentrations of 50, 25, 10, 0% (w/w) diluted in propylene glycol were applied under occlusive condition for 24 hours. Reading was conducted after 24 and 48 hours after removal of occlusive patches.
Results: Following induction up to 50% concentration of the test item in propylene glycol was no skin reaction was observed during this phase.
Challenge phase produced positive skin reactions (grad 2 or more) in twelve animals at 50%, eleven at 25% and nine at 10% concentrations. These reactions were characterised with moderate, confluent redness and in some animals, oedema, scaliness and necrosis was observed. Three control animals showed red spots in reaction to one or two of the tested concentrations. No consistent signs of systemic toxicity were observed in an animal during the study.
Under the condition of the study, it was concluded that the test item, is a sensitiser at a rate of 60%, an indication of moderate sensitivity (Kligman 1966). Applying the general classification and labelling requirements for Directive 67/548/EEC (amended by Directive 83/467/EEC), the test item should be labelled a skin sensitiser.
Reference
Table 2. Individual Bodyweights and Challenge Skin Readings
Animal No. |
Day -1
|
Induction Day 9 Reading |
Day 23 Readings |
Day 24 Readings |
Day 24 |
Comments |
||||||
BWa(gram) |
50a |
50b |
25 |
10 |
0 |
50b |
25 |
10 |
0 |
(BW)a(gram) |
||
Exper. |
|
|||||||||||
106 |
384 |
0 |
2 |
2 |
2 |
0 |
2s |
3s |
3s |
0 |
598 |
Sensitised |
107 |
432 |
0 |
3 |
2 |
2 |
0 |
4cs |
3s |
3s |
0 |
516 |
Sensitised |
108 |
402 |
0 |
1 |
1 |
1 |
0 |
3s |
3s |
3s |
0 |
544 |
Sensitised |
109 |
386 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
521 |
Not sensitised |
110 |
340 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
456 |
Not sensitised |
111 |
386 |
0 |
2 |
1 |
1 |
0 |
2s |
2s |
1s |
0 |
524 |
Sensitised |
112 |
418 |
0 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
0 |
544 |
Sensitised |
113 |
387 |
0 |
2 |
2 |
1 |
0 |
2s |
2 |
2 |
0 |
534 |
Sensitised |
114 |
375 |
0 |
0 |
0 |
0 |
0 |
1s |
1s |
1s |
0 |
508 |
Not sensitised |
115 |
419 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
543 |
Not sensitised |
116 |
412 |
0 |
3 |
2 |
2 |
0 |
3s |
3s |
3s |
0 |
556 |
Sensitised |
117 |
389 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
510 |
Not sensitised |
118 |
412 |
0 |
1 |
1 |
1 |
0 |
2s |
2s |
2s |
0 |
548 |
Sensitised |
119 |
395 |
0 |
0 |
0 |
0 |
0 |
1s |
1 |
1 |
0 |
489 |
Not sensitised |
120 |
373 |
0 |
2 |
1 |
0 |
0 |
2s |
2s |
2s |
0 |
487 |
Sensitised |
121 |
382 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
484 |
Not sensitised |
122 |
390 |
0 |
2 |
0 |
0 |
0 |
1s |
1s |
0 |
0 |
452 |
Sensitised |
123 |
341 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
503 |
Not sensitised |
124 |
373 |
0 |
0 |
1 |
0 |
0 |
2s |
2s |
2s |
0 |
469 |
Sensitised |
125 |
354 |
0 |
3 |
3 |
3 |
0 |
3s |
3s |
3s |
0 |
456 |
Sensitised |
Contr. |
|
|||||||||||
126 |
463 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
625 |
|
127 |
405 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
506 |
|
128 |
412 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
606 |
|
129 |
438 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
525 |
|
130 |
469 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
628 |
|
131 |
476 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
623 |
|
132 |
391 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
515 |
|
133 |
381 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
518 |
|
134 |
406 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
556 |
|
135 |
402 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
545 |
|
a) Bodyweight
b) Concentrations in propylene glycol (% w/w)
c) This site showed brownish discolouration; a sign of necrosis
s) This site showed scaliness
Table 3. Erythema from Exposure of the guinea pig skin from irritation test
Animal no. |
Day -7 BWa (g) |
24 Hour Readingsb |
48 Hour Readingsb |
Day -1 BWa(g) |
||||||
50c |
25 |
10 |
5 |
50c |
25 |
10 |
5 |
|||
136 |
371 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
414 |
137 |
336 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
343 |
138 |
368 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
379 |
139 |
335 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
366 |
a = body weight
b = time after removal of dressing
c = concentrations in propylene glycol (%, v/v)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study in compliance with OECD 406 (1988) was conducted to assess the sensitising potential of the test substance in female guinea pigs of the Dunkin-Hartley strains. One experimental group of 20 animals and one control group of 10 animals were used. The remaining animals were used in the primarily irritation experiments where four animals received an epicutaneous application of the test item in propylene glycol at 50, 25, 10 & 5 % (w/w) in an amount of 0.05ml and one animal received 4 x 0.1 ml intracutaneous injections of 5% (w/w) test item and 0.5 ml 50% (w/w) test item epicutaneously applied. No signs of skin irritation or systemic toxicity was observed in all four animals.
Induction phase: fur from appropriately 4 cm * 6 cm between the shoulders were removed by clipping. Six injections were made over a 2 cm * 4 cm area, for control groups, 0.1 ml of vehicle alone, 0.1 ml Freunds complete Adjuvant (FCA) emulsified with an equal volume of distilled water and 0.1 ml FCA emulsified with an equal volume of propylene glycol. Experimental groups received 0.1 ml test item (5% w/w in propylene glycol), 0.1 ml of Freunds complete Adjuvant (FCA) emulsified with an equal volume of distilled water and 0.1 test item in (10% w/w in propylene glycol) emulsified with equal volume of FCA. The injection site were covered with patch a week later.
On day 7: Control groups received 0.5 ml of vehicle over the injected sites under occlusive condition for 48 hours. While the experimental group received 0.5 ml of the 50% (w/w in propylene
glycol) under occlusive conditions for 48 hours.
Challenge Phase: on day 21, 0.05 ml of the test item at concentrations of 50, 25, 10, 0% (w/w) diluted in propylene glycol were applied under occlusive condition for 24 hours. Reading was conducted after 24 and 48 hours after removal of occlusive patches.
Results: No skin reaction was observed during the induction phase. Challenge phase produced positive skin reactions (grad 2 or more) in twelve animals at 50%, eleven at 25% and nine at 10% concentrations. The reactions were characterised with moderate, confluent redness and in some animals, oedema, scaliness and necrosis was observed. Three control animals showed red spots in reaction to one or two of the tested concentrations. No consistent signs of systemic toxicity were observed in an animal during the study.
Under the condition of the study, it was concluded that the test item, is a sensitiser at a rate of 60%, an indication of moderate sensitivity (Kligman 1966). The test item meets the classification for Cat 1B for skin sensitisation according to GHS and CLP (EC 1272/2008) regulations.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item, is a sensitiser at a rate of 60%, an indication of moderate sensitivity (Kligman 1966). The test item meets the classification for Category 1A for skin sensitisation according to GHS and CLP (EC 1272/2008) regulations.
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.