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Diss Factsheets

Administrative data

Description of key information

not sensitising (guinea pig, OECD TG 406; GPMT/Buehler test; RL2, GLP), 0% sensitisation rate

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991-01-08 to 1991-02-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid GPMT conducted according to guideline is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 256-375 g
- Housing: Collective housing up to a maximum of 5 animals per cage (Macrolon type IV),
- Diet (e.g. ad libitum): ad libitum, Ssniff-G (Alleindiät für Meerschweinchen), pellets, 1.0 cm long, 0.5 cm diameter (SsniffSpezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption from Macrolon drinking bottles, Becker & Co., 460 Castrop-Rauxel
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): Artificial lighting (120 lux), 12 h light/ 12 h dark cycle
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
1% intradermal; 100% epicutaneous
Day(s)/duration:
day 0: intradermal; day 7 dermal application for 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Day(s)/duration:
day 21, 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 female and 10 male (test + control group)
Details on study design:
RANGE FINDING TESTS: yes, the test item was both intrdermal and dermal applied. The following concentrations were used: Intradermal injections: 0.5, 1 and 5%, dermal application: 5, 10, 25, 50 and 100 %. Liquids were used at the highest concentration which did not produce excessive inflammation.

MAIN STUDY
A. INDUCTION EXPOSURE
- Intradermal (day 0)
- Exposure period: intradermal at first stage and after 7 days dermal application for 48 h at second stage
- Test groups:
- 0.1 mL FCA (1:2 in water)
- 0.1 mL test item in water (1% final concentration)
- 0.1 mL test item emulsified in FCA (1% final concentration)
- Control group:
- 0.1 mL FCA (1:2 in water)
- 0.1 mL vehicle
- 0.1 mL vehicle emulsified in FCA (1:2 in FCA)

- Topical Application (day 7)
- Test Group: undiluted test item
- Control Group: vehicle
- Site: An area of 4 x 6 cm over the shoulders, same area as before
- Frequency of applications: First application intradermal and after 7 days dermal application for 48 h.
- Concentrations: Intradermal application 1% and dermal application 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (14 d after second induction exposure)
- Exposure period: 24 h
- Test groups: test item
- Control group: test item
- Site: left flank for test item and right flank for control
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 h

Challenge controls:
10 m + 10 f treated identically, but without test item (only vehicle); challenge: identical to test group
Positive control substance(s):
yes
Remarks:
2,4- dinitrochlorobenzene (extreme sensitizer) and benzocaine (mild sensitizer); last test performed in October, 1990.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no adverse effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
other: detailed results not in the report
Interpretation of results:
GHS criteria not met
Conclusions:
Polyglyceryl-2 caprinate is not a dermal sensitiser in this GPMT study.
Executive summary:

In a dermal sensitisation study according to OECD Guideline 406 (1981) with Polyglyceryl-2 caprinate young adult male and female Pirbright-Hartley guinea pigs (10/sex/group) were tested using the GPMT method.

Based on the results of a preliminary study, the test substance was used at 1% dilution for the intradermal induction (no specific findings), undiluted for epicutaneous induction (slight to moderate erythema) and at 5% dilution (no skin irritation) for the challenge exposure.

Clinical signs, body weight and any skin reactions were evaluated 24 h and 48 h after patch removal. There were no effects observed in the control and the treatment group (sensitisation rate = 0%), thus,

Polyglyceryl-2 caprinate is not a dermal sensitiser in this study.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1997-10-29 to 1998-02-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted July 17, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
dated September 30, 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted according to guideline is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Animal source: Charles River WIGA GmbH, 97320 Sulzfeld, Germany
- Age at study initiation: approximately 30 days
- Weight at study initiation: 313 ± 15 g (n=15)
- Housing: The animals were housed under semi-barrier conditions with up to 5 to a cage (Makrolon Type 4); bedding: ALTROMIN Type S8/15, granulated soft wood bedding (ALTROMIN, 3279 Lage/Lipp, Germany)
- Diet (e.g. ad libitum): ALTROMIN 1322, standard diet for guinea pigs, ad libitum Batch No.: 211297/1556,230198/0956
- Water (e.g. ad libitum): tap water, (municipal supply Bitterfeld) in Makrolon bottles, ad libitum, daily change
- Acclimation period: 8 days before the start of study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24°C
- Humidity (%):30-65%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12h light/12 h dark cycles
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted test item
Day(s)/duration:
3 days/ 6h
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted test item
Day(s)/duration:
1 day/6 hz
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 (test group), 5 (control group)
Details on study design:
RANGE FINDING TESTS: The hair of 2 animals was removed from 4 areas (approximately 2 x 4 cm) overlying the back by clipping/shaving avoiding skin abrasion 24 h prior to topical test article administration. Filter papers (2 x 4 cm²) were loaded with 0.5 g of the test article formulations and applied to the areas in cranial and caudal sequence: 1) undiluted, 2) 50:50 (w/w) test item + Aqua pro injetione, 3) 25:75 (w/w) test item + Aqua pro injetione, 4) 10:90 (w/w) test item + Aqua pro injetione. The papers were covered with tin foil fixed with sticking plaster for 24 h. The administration sites were examined for topical reactions at intervals of 24 and 48 h. The concentration of the test article chosen for the induction and challenge was the undiluted substance, because the test article was non-irritant.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: left flank area (approximately 2 x 6 cm)
- Frequency of applications: day 0, 7 and 14
- Duration: 6 hours
- Concentrations: 0.5 g of the undiluted test item

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank
- Concentrations: 0.5 g of the undiluted test item
- Evaluation (hr after challenge): 24 h and 48 h

Challenge controls:
5 males treated identically, but without test item (only filter papers); challenge: 0.5 g of the undiluted test item
Positive control substance(s):
yes
Remarks:
benzocaine (however, according to GPMT protocol, and thus, not relevant for this study)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: conducted according to GMPT procedure; thus not relevant for this study
Interpretation of results:
GHS criteria not met
Conclusions:
In this Buehler test Polyglyceryl-3 caprate is not a dermal sensitiser.
Executive summary:

In a dermal sensitisation study according to OECD Guideline 406 (1992) and EU method B.6 (1996) with Polyglyceryl-3 caprate young adult male Dunkin-Hartley guinea pigs (10 in test group, 5 in control group) were tested using the Buehler method.

Based on the results of a preliminary study (not irritating at 10, 25, 50 and 100%), the test substance was applied undiluted for induction and challenge exposures.

Clinical signs, body weight and any skin reactions were evaluated 24 h and 48 h after patch removal. There were no effects observed in the control and the treatment group, thus, Polyglyceryl-3 caprate is not a dermal sensitiser in this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a dermal sensitisation study according to OECD Guideline 406 (1981) with Polyglyceryl-2 caprinate young adult male and female Pirbright-Hartley guinea pigs (10/sex/group) were tested using the GPMT method. Based on the results of a preliminary study, the test substance was used at 1% dilution for the intradermal induction (no specific findings), undiluted for epicutaneous induction (slight to moderate erythema) and at 5% dilution (no skin irritation) for the challenge exposure. Clinical signs, body weight and any skin reactions were evaluated 24 h and 48 h after patch removal. There were no effects observed in the control and the treatment group (sensitisation rate = 0%), thus, Polyglyceryl-2 caprinate is not a dermal sensitiser in this study.

  

In a dermal sensitisation study according to OECD Guideline 406 (1992) and EU method B.6 (1996) with Polyglyceryl-3 caprate young adult male Dunkin-Hartley guinea pigs (10 in test group, 5 in control group) were tested using the Buehler method.

Based on the results of a preliminary study (not irritating at 10, 25, 50 and 100%), the test substance was applied undiluted for induction and challenge exposures. Clinical signs, body weight and any skin reactions were evaluated 24 h and 48 h after patch removal. There were no effects observed in the control and the treatment group, thus, Polyglyceryl-3 caprate is not a dermal sensitiser in this study.

 

There are no data gaps for the endpoint skin sensitisation. No human information is available for this endpoint. However, there is no reason to believe that the available results would not be applicable to humans.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be filled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account. For skin sensitisation, there is no reason to believe that results obtained in guinea pigs would not be applicable to humans.

Justification for classification or non-classification

Based on the available data polyglycerin caprylate/caprinate does not need to be classified for sensitisation according to regulation (EC) 1272/2008.