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EC number: 617-638-6 | CAS number: 84868-02-0
- 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
The test item showed no skin sensitising effects on the tested animals. Therefore, it is not a skin sensitiser (reference 7.4.1-1).
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:
- 04-06-1991 to 06-08-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAGNUSSON and KLIGMAN (1969)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig test method described in OECD TG 406 provide suitable information for hazard identification.
- Species:
- guinea pig
- Strain:
- other: Iva: PDH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 300 - 365 g, mean: 323 g
- Housing: Makrolon cages type IV, individual cages
- Diet: ad libitum, Altrorain Standard Diet TPF (R) 3012
- Water: ad libitum, tap water from Makrolon drinking bottles
- Acclimation period: 7 days before the start of the treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 31
- Humidity (%): 42 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- other: with and without Freund's complete adjuvant (FCA)
- Concentration / amount:
- 0.05 %
- Day(s)/duration:
- day 0 / single application
- Adequacy of induction:
- other: slightly irritant
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Liquid paraffin
- Concentration / amount:
- 10 %
- Day(s)/duration:
- day 8 / 48 hours
- Adequacy of induction:
- other: slightly irritant
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Liquid paraffin
- Concentration / amount:
- 1 %
- Day(s)/duration:
- day 22 / 24 hours
- Adequacy of challenge:
- other: not irritant
- No. of animals per dose:
- 2 groups of 10 males and 10 females
- Details on study design:
- Test Item Preparation: The test material was diluted with liquid paraffin or FCA preparation (Freund's complete adjuvant) prior to application.
RANGE FINDING TESTS:
A pretest with single intracutaneous and epicutaneous administration of the vehicle and of the test item preparations was performed, to determine concentrations suitable for the main study.
In the pretest the following concentrations were used:
Vehicle: undiluted
Test item: i.e.: 0.05, 0.5, and 2.5 g ad 100 mL; e.c: 1.0 and 10.0 g ad 100 mL
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 induction stages - 6 injections per induction stage
- Test groups: Group 2: treated with test material preparations
- Control group: Group 1: treated with liquid paraffin (vehicle)
- Site: shoulder region
- Duration: 2 weeks
- Concentrations: Vehicle: Liquid paraffin (undiluted)
Test material: intradermal induction: 0.05 % (slightly irritant), topical induction: 10.00 % (slightly irritant)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: patch soaked with 1 mL test material on the left shaven flank
- Control group: patch soaked with vehicle on the right shaven flank
- Site: left flank of the animal
- Concentrations: topical challenge: 1.00 % (not irritant)
- Evaluation (hr after challenge): 24 and 48
CLINICAL INVESTIGATIONS:
During the induction phase the guinea-pigs were examined daily for local skin reactions, and the results were documented. The challenge sites were investigated for reactions 24 hours after removal of the patches. Further inspections followed 48 hours after challenge, to detect weak or slowly developing reactions, also.
BODY WEIGHT: The body weight of the guinea-pigs was determined prior to the start of the study, and then once weekly. - Challenge controls:
- righ flank of the animal
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
- Positive control results:
- In a separate study, the positiv control DNCB was tested. 100 % positive skin reaction to 0.01 % formulation was determined after 24 and 48 hour readings. The guinea pig strain has been shown to be sensitive and suitible for further testing.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 % formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 % formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % formulation
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.01 % formulation
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.01 % formulation
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Clinical behaviour of the guinea pigs was normal during the study period.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no skin sensitising effects on the tested animals. Therefore, it is not a skin sensitiser.
- Executive summary:
The test item was tested for skin sensitising properties in the guinea-pig maximization test according to MAGNUSSON and KLIGMAN (1969) and OECD 406. 10 males and 10 females per group were investigated. Group 1 was treated with undiluted liquid paraffin (vehicle) and group 2 with the test item (test material preparations). Induction included intradermal injection of the test material (0.05 %, with and without Freund's complete adjuvant) on day 1, and topical application of the test material (10 %) on day 8 of the study. Challenge by topical application of a 1 % test material preparation was performed three weeks after intradermal induction. Treatment with the vehicle did not lead to positive reactions at the 24 h and 48 h readings after challenge. Treatment with the test item as 1 % formulation was without effects at the 24 h and 48 h readings. Under the experimental conditions given, the test item did not show sensitizing properties. According to the grading scheme of MAGNUSSON and KLIGMAN compounds with a sensitization rate of 0 - 8 % have to be classified as weak sensitizers. According to OECD 406 criteria the test item is not considered to possess skin sensitising properties.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Findings in the induction phase
After intradermal injection the usual irritation seen after treatment with Freund's complete adjuvant was observed. The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches scabs and scales were observed at the topical application sites.
Findings after challenge
Group 1 was used as negative control. Challenge on the right flank was performed with the vehicle. On the left flank a single application of a 1.0 % test item formulation was performed to exclude primary irritation. No irritation was observed.
Group 2, the test material group, was exposed to undiluted liquid paraffin on the right and to 1.0 % test item on the left flank. No abnormalities were detected with liquid paraffin and with the test item.
Table 1: Positive reactions (percent) after challenge (sensitization rate)
Group |
Test material |
Time points |
||
24 h |
48 h |
Total |
||
1 |
Liquid paraffin |
0/20 (0 %) |
0/20 (0 %) |
0/40 (0 %) |
2 |
Test item preparation |
0/20 (0 %) |
0/20 (0 %) |
0/40 (0 %) |
Table 2: Challenge reactions at the quinea pig flanks - test item
Group 1: liquid paraffin - undiluted |
Males no. |
||||||||||
Hours |
381 |
382 |
383 |
384 |
385 |
386 |
387 |
388 |
389 |
390 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Females no. |
|||||||||||
Hours |
391 |
392 |
393 |
394 |
395 |
396 |
397 |
398 |
399 |
400 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Group 2: 1 g test item in 100 mL paraffin |
Males no. |
||||||||||
Hours |
361 |
362 |
363 |
364 |
365 |
366 |
367 |
368 |
369 |
370 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Females no. |
|||||||||||
Hours |
371 |
372 |
373 |
374 |
375 |
376 |
377 |
378 |
379 |
380 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Positive reaction after challenge:
24 hours: 0 %
48 hours: 0 %
Total: 0 %
Table 3: Challenge reactions at the quinea pig flanks – positive control
Group 1: liquid paraffin - undiluted |
Males no. |
||||||||||
Hours |
321 |
322 |
323 |
324 |
325 |
326 |
327 |
328 |
329 |
330 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Females no. |
|||||||||||
Hours |
331 |
332 |
333 |
334 |
335 |
336 |
337 |
338 |
339 |
340 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Group 2: 0.01 % positive control formulation |
Males no. |
||||||||||
Hours |
301 |
302 |
303 |
304 |
305 |
306 |
307 |
308 |
309 |
310 |
|
24 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
48 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
Females no. |
|||||||||||
Hours |
311 |
312 |
313 |
314 |
315 |
316 |
317 |
318 |
319 |
320 |
|
24 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
48 |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
Positive reaction after challenge:
24 hours: 100 %
48 hours: 100 %
Total: 100 %
Clinical findings and mortality
The clinical behavior of the guinea-pigs was normal during the study period. All animals survived the study period.
Body weight
The body weight development did not differ from that of the animals of the vehicle group. All animals survived the study period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
OECD 406
The test item was tested for skin sensitising properties in the guinea-pig maximization test according to MAGNUSSON and KLIGMAN (1969) and OECD 406. 10 males and 10 females per group were investigated. Group 1 was treated with undiluted liquid paraffin (vehicle) and group 2 with the test item (test material preparations). Induction included intradermal injection of the test material (0.05 %, with and without Freund's complete adjuvant) on day 1, and topical application of the test material (10 %) on day 8 of the study. Challenge by topical application of a 1 % test material preparation was performed three weeks after intradermal induction. Treatment with the vehicle did not lead to positive reactions at the 24 h and 48 h readings after challenge. Treatment with the test item as 1 % formulation was without effects at the 24 h and 48 h readings. Under the experimental conditions given, the test item did not show sensitizing properties. According to the grading scheme of MAGNUSSON and KLIGMAN compounds with a sensitization rate of 0 - 8 % have to be classified as weak sensitizers. According to OECD 406 criteria the test item is not considered to possess skin sensitising properties (reference 7.4.1-1).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified as a skin sensitiser under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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