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Diss Factsheets

Administrative data

Description of key information

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:
1999-01-18 to 1999-03-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study. Acceptable deviation from OECD Guideline 406 (adopted 1992): skin reactions after induction treatment were not reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted July 17, 1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals Inc., Scottdale, Pennsylvania, USA
- Age at study initiation: not specified
- Weight at study initiation: males 358 g to 414 g; females 363 g to 406 g
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Guinea Pig Chow #5026 (Purina Mills, Inc.) ad libitum
- Water: Municipal tap water treated by reverse osmosis ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-22°C
- Humidity: 21-56%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle

IN-LIFE DATES: From: 1999-01-28 (Dose Range Finding) To: 1999-03-06 (Scoring main study)
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- Topical range-finding study: 100% and at 25%, 50% and 75% w/v in deionized water
- Intradermal range-finding study: 0.1%, 1.0%, 3.0% and 5.0% w/v in deionized water
- Sensitization study: the test article was utilized at 5.0% w/v in deionized water (intradermal induction) and at 100% (topical induction, challenge and rechallenge).
Route:
other: Hilltop Chamber, epicutaneous
Vehicle:
water
Concentration / amount:
- Topical range-finding study: 100% and at 25%, 50% and 75% w/v in deionized water
- Intradermal range-finding study: 0.1%, 1.0%, 3.0% and 5.0% w/v in deionized water
- Sensitization study: the test article was utilized at 5.0% w/v in deionized water (intradermal induction) and at 100% (topical induction, challenge and rechallenge).
No. of animals per dose:
Topical and intradermal Range-Finding Study: 2 males and 2 females each
Sensitization study: 10 males and 10 females
Challenge control and re-challenge control: 5 males and 5 females each
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures
- intradermal (test animals): three pairs of injections on day 0
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of 5.0% test item in deionized water
c. Injection Pair C: 0.1 mL of 5.0% test item/FCA emulsion
- challenge and rechallenge control animals received the same treatment, except test item
- topical: Following clipping , 0.5 mL of 10% w/w sodium lauryl sulfate in petrolatum was spread over the intradermal injection sites on day 6. On day 7, any residual sodium lauryl sulfate preparation was removed, and test item (100% ) or deionized water was applied to the test item or control groups respectively.
- Exposure period, topical: 48 hours (after dosing, the elastic wrap, tape and patch were removed)
- Test groups: one test group
- Control group: a challenge control group and a rechallenge control group

B. CHALLENGE EXPOSURE
- No. of exposures: once, plus one re-challenge to test group
- Day of challenge: day 20
- Day of re-challenge: day 28
- Exposure period: approximately 24 hours
- Test groups: one test group
- Control group: a challenge control group and a rechallenge control group
- Concentrations: 100% test item
- Evaluation: approximately 24 and 48 hours following chamber removal
Positive control substance(s):
yes
Remarks:
Reliability check: alpha-hexylcinnamaldehyde, performed during the past six months
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:
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:
test chemical
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.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

The dermal sensitization potential of the test item was evaluated in Hartley-derived albino guinea pigs according to OECD TG 406 adopted 1992-07-17. Ten male and ten female guinea pigs received intrademnal injections of 5.0% w/v of the test item in deionised water along with injections of FCA and the test item in FCA. Following challenge with 100% test item, dermal scores of 0 were noted in all test and challenge control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the challenge control animals. Following rechallenge with 100% test item, dermal scores of 0 were noted in all test and rechallenge control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the rechallenge control animals. Based on the results of this study, according to the criteria as laid down in Regulation (EC) No 1272/2008 (CLP) the test item is not considered to be a contact sensitizer in guinea pigs.

 

Human data
The objective of this study (see IUCLID section 7.10) was to evaluate the test articles for the induction of contact sensitization by repetitive applications to the skin of human volunteers. The study design is an adaptation of the Draize Patch Test. One hundred and four subjects (32 male, 72 female) completed all phases of the study. Three adverse events were reported during the course of the study. None of these events were related to the test articles. Under the conditions of this study, test item does not appear to exhibit the potential for contact sensitization at either test concentration. In addition, the test article did not appear to cause significant irritation potential during the three week induction period or during the challenge phase of the study.


Migrated from Short description of key information:
The test item was tested for skin sensitisation in a GLP study according to OECD 406 in guinea pigs. The test item is not considered to be a contact sensitizer in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Only one GLP and guideline compliant study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data on sensitisation the test item ist not subjected to classification and labelling according to Regulation 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).