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EC number: 274-434-6 | CAS number: 70210-37-6
- 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
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:
- From March 7th to September 21st, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test results described do not totally comply with the specific testing guideline but they are sufficient to accept the data.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was already existing when LLNA was introduced in the Regulation
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (Saint-Aubin-Lès-Elbeuf, 76410 Cléon, France).
- Age at initiation of treatment: young adult (about 6 weeks old).
- Body weight range at initiation of treatment: 250 - 550 g.
- Diet: pelleted complete guinea-pig diet ad libitum
- Water: softened and filtered mains drinking water, ad libitum analysed at least once a year for chemical contaminants and at least twice a year for bacterial contaminants
- Caging: animals housed in groups according to EEC/86/609 in stainless steel mesh cages (internal dimensions 500 x 600 x 200 mm).
ENVIRONMENTAL CONDITIONS
- Housing: in an air-conditioned building (building G4)
- Temperature : 19 ± 3 °C
- relative humidity : ≥ 31 % R.H.
- air changes : ≥ 22 air changes per hour
- lighting cycle : 12 hours light (artificial)/12 hours dark - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- PRELIMMINARY STUDIES:
- one injection of 0.1 ml per area and per animal, of the test article in a 5 % suspension or in a 1 % or 0.1 % (W/W) solution in water for injection.
- 0.5 ml per area and per animal of the test article in a 57 % or 28 % (W/W) paste in water for injection.
- 0.5 ml per area and per animal of the test article in a 10 % (W/W) suspension or in a 1 % (W/W) solution in water for injection.
MAIN STUDY:
- 0.5 ml per animal of the test article in a 1 % (W/W) solution in water for injection. - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- PRELIMMINARY STUDIES:
- one injection of 0.1 ml per area and per animal, of the test article in a 5 % suspension or in a 1 % or 0.1 % (W/W) solution in water for injection.
- 0.5 ml per area and per animal of the test article in a 57 % or 28 % (W/W) paste in water for injection.
- 0.5 ml per area and per animal of the test article in a 10 % (W/W) suspension or in a 1 % (W/W) solution in water for injection.
MAIN STUDY:
- 0.5 ml per animal of the test article in a 1 % (W/W) solution in water for injection. - No. of animals per dose:
- • preliminary studies (minimum of 3) : 2 males, 2 non-pregnant females, per study.
• main study :
- control group -> 5 males, 5 nulliparous non-pregnant females.
- treated group -> 10 males, 10 nulliparous non-pregnant females. Two extra guinea-pigs (1 male and 1 female) will also be treated to allow for any possible non-treatment related deaths.
- option : positive control group -> 5 males, 5 nulliparous non-pregnant females. - Details on study design:
- During induction, the applications were performed as follows :
• Treated group :
- By intradermal route: 3 series of 2 x 0.1 ml injections
Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution;
test article in a 5 % (w/w) suspension in water for injection;
mixture 50/50 (V/V): test article in a 5 % (w/w) suspension in water for injection + Freund's complete adjuvant at 50 % (V/V) in an isotonic injectable solution, i.e. a final 2.5 % concentration of the test article .
During the preliminary study, injection of the test article in a 5 % suspension tinted the skin of the animals thus making observation of erythema impossible. No oedema was noted.
- By topical occlusive route for 48 hours, with 0.5 ml of the test article in a 57 % (w/w) paste in water for injection.
During the preliminary study, the test article tinted the skin of the animals thus making observation of erythema impossible. Nevertheless as no oedema was noted, a skin painting was performed during the main study on Day 8, with 0.5 ml of sodium lauryl sulphate at 10 % (w/w) in Codex paraffin to create irritation.
• Control group:
The intradermal injections and the topical occlusive application for 48 hours were carried out under the same conditions as in the treated group, water for injection replacing the test article.
The rest period was 11 days without treatment.
During the challenge, the topical occlusive application for 24 hours was performed in the treated group and in the control group with the test article in a 1 % (w/w) solution in water for injection and at the dose level of 0.5 ml. The cutaneous macroscopic examinations were performed 24 and 48 hours after removal of the patches to the challenge application site, according to the Magnusson & Kligman scale.
As the test article tinted the skin of the animals, thus making observation of erythema impossible, histopathological examinations of the skin were performed for all the animals of the treated and control groups (in half of them at 24 hours and in the other half at 48 hours). - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene
- Positive control results:
- 80 to 100 % of sensitized animals are usually obtained.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % solution
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Details are repotrted below
- Remarks on result:
- other: The full result table is attached below
- Group:
- positive control
- Remarks on result:
- other: See table below
- Group:
- negative control
- Remarks on result:
- other: See table below
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not sensitising
- Executive summary:
METHOD:
The guinea pig maximisation test (GPMT) was chosen as test method used to evaluate skin sensitisation potential. The test was performed according to the OECD Guideline 406 (1992).
RESULTS:
Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups.
After challenge, the macroscopic and histopathological examinations revealed pathological lesion of delayed hypersensitivity in 1 out of the 20 treated animals. No noticeable cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group.
CONCLUSION:
According to the CLP Regulation (EC n. 1272/2008), a substance is classified as skin sensitiser when in the Guinea pig maximisation test the response of at least 30 % of the animals is considered as positive.
In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This different in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC n. 1272/2008).
Reference
Treated groups:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | M62531 | M62533 | M62535 | M62537 | M62539 | M62534 treated area | M62534 control area | M62536 | M62538 | M62540 | M6262541 |
EPIDERMIS | |||||||||||
Acanthosis | moderate | minimal | minimal | minimal | slight | slight | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | slight | slight | moderate | moderate | moderate | moderate | marked | moderate | moderate | marked |
Exocytosis | minimal (focal) | - | - | - | - | minimal (focal) | - | - | - | - | - |
Spongiosis | minimal (basal) | - | - | - | minimal (basal) | minimal (focal) | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight | slight | slight | slight | slight | slight | slight (1) | slight | slight | slight |
Folliculitis | - | - | - | - | minimal | - | - | - | - | - | - |
Oedema | minimal | - | - | - | - | - | - | - | - | - | - |
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | F62543 | F62545 | F62547 treated area | F62547 control area | F62549 | F62551 | F62542 | F62544 | F62546 | F62548 | F62550 |
EPIDERMIS | |||||||||||
Acanthosis | slight | slight | minimal | slight | slight | moderate | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | moderate | moderate | moderate | moderate | marked | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | minimal (multifocal) | - | - | - | - | - | - | - |
Spongiosis | - | - | - | minimal (basal) | - | - | - | - | - | - | - |
Scab(s) | - | present | - | - | - | - | present | - | - | - | - |
Ulceration | - | minimal (focal) | - | - | - | - | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight (1) | minimal | slight (1) | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | - | - | minimal | - |
Oedema | - | - | - | - | - | - | - | - | - | - | - |
Control group:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | |||||||||
Animal (sex,number) | M62521 | M62523 | M62525 | F62527 | F62529 | M62522 | M62524 | M62526 | F62528 | F62530 |
EPIDERMIS | ||||||||||
Acanthosis | minimal | - | minimal | slight | slight | minimal | minimal | slight | minimal | slight |
Hyperkeratosis | slight | slight | moderate | moderate | moderate | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | - | minimal (focal) | minimal (focal) (1) | - | - | - | - |
Spongiosis | - | - | - | - | minimal (basal) | slight (focal) | - | - | - | - |
scab(s) | - | - | - | - | - | - | - | - | - | present |
DERMIS | ||||||||||
Mononuclear cell infiltration | minimal | minimal | minimal | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | minimal (focal) | - | minimal (focal) |
Oedema | - | - | - | - | - | - | - | - | - | - |
(1) with some polymorphs
Male no. 62534 showed on the treated area a minimal focus of spongiosis associated with exocytosis which could be due to cell mediated delayed hypersensitivity. Other changes seen in all animals were consistent with a minimal to slight local irritation due to the technical procedures.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The guinea pig maximisation test (GPMT) was chosen as test method used to evaluate skin sensitisation potential. The test was performed according to the OECD Guideline 406 (1992).
In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This different in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC 1272/2008).
Migrated from Short description of key information:
Not sensitising
Justification for selection of skin sensitisation endpoint:
The test results described do not totally comply with the specific testing guideline (OECD 406) but they are sufficient in quantity and quality to permit an evaluation of the effects of the test substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the CLP Regulation (EC n. 1272/2008), in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.
A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).
If, in order to evaluate skin sensitisation potential, a Guinea pig maximisation test is performed, a substance is classified as skin sensitiser when the response of at least 30 % of the animals is considered as positive.
In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This difference in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC n. 1272/2008).
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