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Administrative data

Description of key information

A Guinea-Pig Maximisation Test performed according to OECD 406 test guideline with Cocamidopropyl hydroxysultaine as a 42% solution is available which shows the substance is not a skin sensitisier.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January to February 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP and OECD 406-compliant study, but no dose-range finding procedure is described and no positive control test substance was included whereas the 100% concentration tested was not irritant. In addition, no test substance batch number was reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The skin sensitisation study was conducted prior to the LLNA being the study type of choice.
Specific details on test material used for the study:
Appearance: Light yellow clear, slightly viscous liquid
Storage: Room temperature
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal
- Weight at study initiation: 229-284 g
- Housing: maximum of 5 animals per cage
- Caging: Makrolon type IV cage (20 x 33 x 55 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimitisation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 50-85
- Photoperiod: 12 hours light/dark cycle

IN-LIFE DATES: From: 5 January 1988 To: 5 February 1988
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
deionised
Concentration / amount:
10% for intradermal induction
100% for topical induction
Day(s)/duration:
Topical induction 7 days after intradermal induction; 48 hour topical induction
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%/0.5 mL
Day(s)/duration:
24 hour exposure
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Twenty
Details on study design:
RANGE FINDING TESTS: Two Guinea-pigs received a dermal application of the test item at 100% (0.5 mL per animal) under occlusive conditions.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal + topical)
- Exposure period: One week
- Test groups: One test group receiving test solution at 10% in deionised water, 10% in Freund's Complete Adjuvant (FCA) and undiluted FCA (0.05 mL per injection) [intradermal] + Undiluted test solution (0.5 mL) [topical]
- Control group: One control group receiving undiluted FCA, deionised water 10% in FCA and undiluted deionised water (0.05 mL per injection) [intradermal] + Deionized water (0.5 mL) [topical]
- Site: 2 injections sites arranged in pairs bilaterally to spinal column
- Frequency of applications: Topical induction 7 days after intradermal one
- Duration: Acute (intradermal) / 48 h (topical)
- Concentrations: 10% (intradermal) / 100% (topical)

B. CHALLENGE EXPOSURE
- No. of exposures: 1 occlusive patch
- Day(s) of challenge: 3 weeks following intradermal induction
- Exposure period: 24 hours
- Test groups: Undiluted test solution (0.5 mL)
- Control group: Undiluted deionised water (0.5 mL)
- Site: Same as intradermal injection sites
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after patch removal
Challenge controls:
Water was used as the vehicle control
Positive control substance(s):
no
Positive control results:
Not applicable.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 - water only
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 -water
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Cocamidopropyl hydroxysultaine, as a 42% solution, is not considered a skin sensitiser.
Executive summary:

In a Guinea-Pig Maximisation Test performed according to OECD No. 406 test guideline, Cocamidopropyl hydroxysultaine as a 42% solution was tested for its skin sensitising potential in Pirbright guinea pigs. A preliminary test on two animals using the test solution at 100% showed that this concentration was appropriate for topical application. For the main test, 20 animals were applied the vehicle (deionised water) only (control group) and 20 other animals were applied the test substance. For the induction phase, animals received an intradermal injection of the test substance at 10% in deionised water or in Freund’s Complete Adjuvant (FCA) emulsion. One week later, a second induction was performed by a topical application of the test solution at 100%. Two weeks after the topical induction phase, challenge was performed by applying the test substance at 100% topically under occlusive conditions for 24 hours. Observation and grading of skin reactions was performed 24 and 48 hours after patch removal to assess potential sensitisation. No skin reaction and therefore no sign of sensitisation was observed 24 and 48 hours after the challenge in any animal (control or treated groups). Therefore, under the conditions of this test, Cocamidopropyl hydroxysultaine as a 42% solution is not considered as a skin sensitiser according to the criteria of Regulation (EC) 1272/2008 (CLP).

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a Guinea-Pig Maximisation Test performed according to OECD 406 test guideline, Cocamidopropyl hydroxysultaine tested as a 42% solution showed no skin reaction and therefore no sign of sensitisation when assessed 24 and 48 hours after a challenge in any animal (control or treated groups). Therefore, under the conditions of this test, Cocamidopropyl hydroxysultaine as a 42% solution is not considered as a skin sensitiser according to the criteria of Regulation (EC) 1272/2008 (CLP).