Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
January-February 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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. The study was performed on an analogue substance (for justification of read-across between Lauramidopropylhydroxysultaine and cocamidopropylhydroxysultaine, please refer to corresponding assessment report in Section 13).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Slightly viscous liquid
Details on test material:
- Name of test material (as cited in study report): REWOTERIC(R) AM CAS
- Substance type: liquid
- Physical state: Light yellow, clear, slightly viscous liquid
- Analytical purity: 42% CAS 68139-30-0 (data not included in study report)
- Impurities: Free amidoamines < 1% (data not reported, see certificate attached in background material)
- Lot/batch No.: 34024 (data not reported, see certificate attached in background material)
- Storage condition of test material: at room temperature, in the dark
- Other: test material supplied by Rewo Chem. Werke GmBH, Steinau, Germany

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal
- Age at study initiation: No data
- Weight at study initiation: 229-284 g
- Housing: max. 5 animals per Makrolon type IV cage (20 x 33 x 55 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50-85
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12 (7.00 am-7.00 pm)

IN-LIFE DATES: From: 5 January 1988 To: 5 February 1988

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: deionised water
Concentration / amount:
- Induction: 10%
- Challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: deionised water
Concentration / amount:
- Induction: 10%
- Challenge: 100%
No. of animals per dose:
20 test + 20 control animals
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
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 Directive 67/548/EEC (DSD) or Regulation (EC) 1272/2008 (CLP).