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Endpoint summary
Administrative data
Description of key information
The test material Santicizer P1400 was investigated to determine the potenzial to promot skin sensitivity according to the Ritz&Buehler method in compliance with the OPPTS 870.2600 and OECD 406 Guidelines.
For the induction phase, a dose of 0.4 ml (100% concentration) was applied to the left shoulder area (25mm area) of 10 male and 10 females guinea pigs (Group1). After the dosing, the torso was wrapped with no-irritant tape to provide occlusion. The site was exposed for 6 hours and then clean with ethanol. The procedure was repeated for 3 consecutive weeks, once/week. Group 2 (5 males and 5 females were used as negative control and, therefore, not treated). After 14 days for the last treatment, animals of Group 1 and 2 were challanged following the same procedure ad for the induction. The dose was applied on the lower left dorsal area.
The result of the study showed that erythema was absent in both the induced and negative control groups. The body weights changes were normal as the clinical observations.
Based on the results of this study, the test material Santicizer Platinum P1400 was not a sensitizer.
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:
- 2010-08-11 to 2011-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Scientifically valid and acceptable delayed contact dermal sensitization test in guinea pigs. The study was conducted in the US in 2011.
- Specific details on test material used for the study:
- Label Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 08/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Sample preparation: Induction and challange - The test article was used as received.
Screen: Used as received (100% concentration) and was dissolved in ethanol and diluted to appropriate concentrations (10, 25 and 50) with distilled water (opaque liquid).
TEST DATES:
Study Initiation: 08 November 2010
Experimental Start Date: 10 November 2010
Experimental Term Date: 16 December 2010
Draft Report Signed: 06 January 2011
Final Report Signed: 03 March 2011 - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Inc., Chelmsford, MA
- Age at study initiation:
- Weight at study initiation: Male: 277-474 g - Female: 300-465 g
- Housing: suspended wire cages
- Diet (e.g. ad libitum): PMI Guinea Pig Chow - ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): This parameter deviated from the standard protocol. This did not have any effect on the study animals and the integrity of the study.
- Humidity (%): This parameter deviated from the standard protocol. This did not have any effect on the study animals and the integrity of the study.
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12 hr light and 12 hr dark
IN-LIFE DATES: From: 11/10/10 to12/06/11 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 ml
- Day(s)/duration:
- 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 mL
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 males and 10 females ( 0.4 mL concentration)
5 males and 5 females (control) - Details on study design:
- Site preparation:
Site 1 and 2: tests
Site 3 and 4: alternative site in the event that severe irritation was noted
SCREEN:
Each animal received 4 concentration of the test article, one/site. Each concentration (10, 25, 50, 100%) was placed in 25 mm Hilltop Chamber contained a cotton pad. The sites were covered with a strip of rubber dental dam to cover the treated sites and wrapped with tape to provide occlusion. After 6 hours the dams and test article were removed and the sites cleaned with distilled water and dried with a soft towel.
INDUCTION EXPOSURE
Group 1 (10 males and 10 females) was treated with 0.4 ml of the test article (100%). The dose was applied to the left shoulder area (site1) using 25 mm Hilltop Chamber contained a cotton pad in order to facilitate the contact of the liquid test article with the site. The chamber was covered with a strip of rubber dental dam and the torso was wrapped with no-irritant tape to provide occlusion. After 6 hours, the dam and test articles were removed and the site was cleaned with ethanol.
This procedure was performed one/week for three weeks. Group 2 (5 males and 5 females) were untreated for three weeks induction and served as negative control.
CHALLENGE EXPOSURE
After 14 days from the last induction, the animals of Group 1 and 2 were challanged using the same dosing procedure as in the induction phase. 100% was chosen as the highest non-irritating concentration for the challange (based on the screen results). The doses were applied to Site 3, lower left dorsal area. - Challenge controls:
- 5 males and 5 females
- Positive control substance(s):
- yes
- Remarks:
- HCA
- Positive control results:
- Hexylcinnamaldehyde, HCA: Incidence index : 24 hr: 0.05; 48 hr: 0.32. Severity index 24 hr: 0.18; 48hr: 0.39 - Historic data retested every 6 months in the lab.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: Naive to induction
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic abnormalities
- Remarks on result:
- other: Naive to induction
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: First induction
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Mo systemic abnormalities
- Remarks on result:
- other: First induction
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: Second induction
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: Second induction
- Key result
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: Third induction
- Key result
- Reading:
- other:
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- other: Third induction
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormal systemic observations
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: HCA Positive control data retested every 6 months
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- HCA (85%)
- Remarks on result:
- other: Incidence index 0.05
- Remarks:
- Severity index 0.18
- Key result
- Reading:
- other: HCA Positive control restested every 6 months
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- HCA (85%)
- Remarks on result:
- other: Incidence index 0.32
- Remarks:
- Severity index 0.39
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not sensitising
- Conclusions:
- Based on the results observed, Santicizer P1400 was determined to not be a dermal sensitizer under the conditions of this delayed contact dermal sensitization test in guinea pigs.
- Executive summary:
In a key EPA OPPTS Guideline 870.2600 delayed contact dermal sensitization study, the potential of the test material (Santicizer P1400) to promote skin sensitization reactions following repeated applications was evaluated in guinea pigs using the Buehler method.
Seventeen healthy male and female Hartley Albino guinea pigs were utilized in the study. Four guinea pigs were used to screen for the highest non-irritating concentration which produced scores no more severe than two scores 0.5 and two scores of 0. Based on the results of this screen, 100% was selected as the highest non-irritating concentration for the challenge and administered to two groups of guinea pigs (Group 1 and Group 2) two weeks subsequent to the third induction.
Group 1 (10 males and 10 females) was induced with the test material at a concentration of 100%. Group 2 (5 males and 5 females) animals were not induced and served as the naïve control. For the induction phase, a dose of 0.4 mL (100% concentration) was applied to the left shoulder area (25 mm2area) of 10 male and 10 females guinea pigs in Group1. After application, the torso was wrapped with non-irritant tape to provide occlusion. The site was exposed for 6 hours and then cleaned with ethanol. Group 1 animals received three topical induction applications, one per week for three weeks. Skin reactions of all animals were recorded 24 and 48 hours following patch removal. 14 days after the last treatment, animals of Group 1 and 2 were challenged following the same procedure as used for the induction phase. The dose was applied on the lower left dorsal area. Body weights were recorded pretest and at termination and all animals were observed once per day for mortality and toxicity. 85% hexylcinnemaldehyde (HCA) was the historical positive control with its toxicity confirmed in the laboratory every six months.
No mortality was observed and body weight changes in all animals were normal through the study period. Treated as well as control animals appeared normal through the observation period. Erythema was absent at induction as well as at challenge in both the induced as well as naïve control groups.
Based on the results observed, Santicizer P1400 was determined to not be a dermal sensitizer under the conditions of this delayed contact dermal sensitization test in guinea pigs.
Reference
Table 1. Results |
||||
Challenge |
Incidence Index |
Severity Index |
||
24 hours |
48 hours |
24 hours |
48 hours |
|
Santicizer P1400 |
0 |
0 |
0 |
0 |
Naïve Control |
0 |
0 |
0 |
0 |
Historical Positive Controla |
|
|||
HCA Positive Control |
0.05 |
0.32 |
0.18 |
0.39 |
Naïve Control |
0 |
0 |
0 |
0 |
aHistorical Positive Control data (MB 10-19286.06) attached in Appendix A of the study report.
Table 2. Dermal Observations and Body Weights (g) - Screen |
|||||
Animal No. / sex |
Pretest Body Weight (g) |
Site |
Concentration (%) |
Erythema |
|
24 hours |
48 hours |
||||
D4195 / Male |
464 |
1 |
100 |
0.5 |
0 |
2 |
50 |
0 |
0 |
||
3 |
25 |
0 |
0 |
||
4 |
10 |
0 |
0 |
||
|
|||||
D4196 / Male |
474 |
1 |
100 |
0.5 |
0 |
2 |
50 |
0 |
0 |
||
3 |
25 |
0 |
0 |
||
4 |
10 |
0.5 |
0 |
||
|
|||||
D4197 / Female |
465 |
1 |
100 |
0 |
0 |
2 |
50 |
0 |
0 |
||
3 |
25 |
0 |
0 |
||
4 |
10 |
0 |
0 |
||
|
|||||
D4198 / Female |
410 |
1 |
100 |
0 |
0 |
2 |
50 |
0 |
0 |
||
3 |
25 |
0 |
0 |
||
4 |
10 |
0 |
0 |
Table 3. Dermal Observations: Group 1 Post Patch Removal (Induction) – 0.4 mL (100% Concentration) |
||||||
Animal No. / Sex |
Induction 1, Erythema Site# 1 |
Induction 2, Erythema Site# 1 |
Induction 3, Erythema Site# 1 |
|||
24 hours |
48 hours |
24 hours |
48 hours |
24 hours |
48 hours |
|
D4271 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4272 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4273 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4274 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4275 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4276 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4277 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4278 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4279 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
D4280 / Male |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||
D4281 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4282 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4283 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4284 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4285 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4286 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4287 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4288 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4289 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
D4290 / Female |
0 |
0 |
0 |
0 |
0 |
0 |
Table 4. Body Weight (Group 1): Induction |
||
Animal No. / sex |
Pretest (g) |
Term (g) |
D4271 / Male |
288 |
520 |
D4272 / Male |
303 |
489 |
D4273 / Male |
277 |
528 |
D4274 / Male |
293 |
529 |
D4275 / Male |
307 |
541 |
D4276 / Male |
311 |
513 |
D4277 / Male |
346 |
645 |
D4278 / Male |
294 |
520 |
D4279 / Male |
315 |
588 |
D4280 / Male |
289 |
515 |
Mean |
302 |
539 |
S.D. |
19.3 |
45.1 |
# |
10 |
10 |
|
||
D4281 / Female |
357 |
567 |
D4282 / Female |
314 |
492 |
D4283 / Female |
317 |
433 |
D4284 / Female |
308 |
482 |
D4285 / Female |
312 |
514 |
D4286 / Female |
316 |
494 |
D4287 / Female |
300 |
523 |
D4288 / Female |
354 |
549 |
D4289 / Female |
305 |
451 |
D4290 / Female |
318 |
416 |
Mean |
320 |
492 |
S.D. |
19.5 |
48.7 |
# |
10 |
10 |
Table 5. Dermal Observations: Groups 1 and 2 Post Patch Removal (Challenge) |
|||||
Animal No. / sex |
Challenge Erythema (100% Concentration) Site# 3 |
Animal No. / sex |
Challenge Erythema (Naïve Control) Site# 3 |
||
24 hours |
48 hours |
24 hours |
48 hours |
||
D4271 / Male |
0 |
0 |
D4291 / Male |
0 |
0 |
D4272 / Male |
0 |
0 |
D4292 / Male |
0 |
0 |
D4273 / Male |
0 |
0 |
D4293 / Male |
0 |
0 |
D4274 / Male |
0 |
0 |
D4294 / Male |
0 |
0 |
D4275 / Male |
0 |
0 |
D4295 / Male |
0 |
0 |
D4276 / Male |
0 |
0 |
|
|
|
D4277 / Male |
0 |
0 |
|
|
|
D4278 / Male |
0 |
0 |
|
|
|
D4279 / Male |
0 |
0 |
|
|
|
D4280 / Male |
0 |
0 |
|
|
|
|
|||||
D4281 / Female |
0 |
0 |
D4296 / Female |
0 |
0 |
D4282 / Female |
0 |
0 |
D4276 / Female |
0 |
0 |
D4283 / Female |
0 |
0 |
D4298 / Female |
0 |
0 |
D4284 / Female |
0 |
0 |
D4299 / Female |
0 |
0 |
D4285 / Female |
0 |
0 |
D4300 / Female |
0 |
0 |
D4286 / Female |
0 |
0 |
|
|
|
D4287 / Female |
0 |
0 |
|
|
|
D4288 / Female |
0 |
0 |
|
|
|
D4289 / Female |
0 |
0 |
|
|
|
D4290 / Female |
0 |
0 |
|
|
|
Table 6. Body Weight (Naïve Controls - Group 2): Challenge |
||
Animal No. / sex |
Pretest (g) |
Term (g) |
D4291 / Male |
319 |
640 |
D4292 / Male |
312 |
558 |
D4293 / Male |
294 |
535 |
D4294 / Male |
310 |
581 |
D4295 / Male |
349 |
648 |
Mean |
317 |
592 |
S.D. |
20.2 |
49.9 |
# |
5 |
5 |
|
||
D4296 / Female |
356 |
487 |
D4276 / Female |
352 |
535 |
D4298 / Female |
326 |
542 |
D4299 / Female |
308 |
438 |
D4300 / Female |
316 |
424 |
Mean |
332 |
485 |
S.D. |
21.5 |
54.0 |
# |
5 |
5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The result of the study showed that the test material Santicizer Platinum P1400 is not a sensitizer.
Justification for selection of skin sensitisation endpoint:
The study was conducted according to EPA guideline and GLP conditions. It is fylly adequate for assessment.
The result of the study showed that the test material Santicizer Platinum P1400 is not a sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
P1400 does not meet the criteria for classification as a skin sensitizer under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.