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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
no analytical purity reported; no information about positive control
GLP compliance:
yes
Remarks:
Bezirksregierung, Lüneburg, Germany
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Constituent 1
Reference substance name:
130905-60-1
EC Number:
603-445-4
Cas Number:
130905-60-1
IUPAC Name:
130905-60-1

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white; Bor: DHPW (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TTEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen, Germany
- Weight at study initiation: 292 – 409 g
- Housing: 5 animals of the same sex per cage in Macrolon cages type IV
- Diet: Ssniff-G (Alleindiät für Meersschweinchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 3.5
- Humidity (%): 50 – 85
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil/petrolatum
Concentration / amount:
5% (intradermal), 25% (epicuteneous)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil/petrolatum
Concentration / amount:
25%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Intradermal injection: two animals (one male and one female) were injected 5% test item in diluted in FCA/water. At this concentration no specific skin reaction were found. Therefore 5% was the concentration chosen for the intradermal injection.
Dermal application: Two animals were applied with 25% pasty test article moistened in petrolatum by means of an occlusive dressing. No skin reactions were recorded 48 h post applicationem. Thus, 25% was the concentration chosen for the epicutaneous exposure


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1: 1 mixture (v/v) FCA/water
Injection 2: test substance in petrolatum
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water

Epicutaneous: test substance in petrolatum

- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/V) FCA/water
Injection 2: corn oil/petrolatum
Injection 3: at 50% (w/v) in a 1:1 mixture (v/v) FCA/water

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 25%

Epicutaneous: petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank (test substance) and right flank (vehicle)
- Concentrations: 25%
- Evaluation (hr after challenge): 48 an 72 h
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 5%, challenge 25%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified