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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-06-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The most important deviations from the guideline were: no results of a reliability check were provided; no results of the induction application were provided; the dose-selection is unclear
GLP compliance:
no
Remarks:
Older study, predates mandatory GLP
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the adoption of the OECD test guideline (OECD 429) for the LLNA, in 2010

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea
EC Number:
266-096-3
EC Name:
1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea
Cas Number:
66063-05-6
Molecular formula:
C19H21ClN2O
IUPAC Name:
1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
DHPW
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 280 - 375 g.
- Housing: The animals were kept, five to a Makrolon cage type IV.
- Diet: Altromin 3022 Diet for guinea pigs, ad libitum
- Water: drinking water from bottles, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22-24° C
- Humidity: 30-50 %
- Photoperiod: light/dark rhythm 12 hours.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Cremophor EL/physiological saline
Concentration / amount:
1%
Day(s)/duration:
Day 1
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor EL/physiological saline
Concentration / amount:
25%
Day(s)/duration:
Topical induction was performed for 48 hours, one week after intradermal injection
Adequacy of induction:
other: Although the highest topical induction concentration of 25% w/v did not result in a skin reaction, this concentration is considered to be sufficient, as it is near the maximum concentration for powders to obtain a well-mixed suspension (ca. 30%).
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Cremophor EL/physiological saline
Concentration / amount:
25%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Three animal groups (one test compound and two control groups) each consisting of 20 male animals (test compound group) and ten males (control groups)
Details on study design:
RANGE FINDING TESTS:
The doses in the main study were based on the results of a range-finding study using 0, 1, 2.5, and 5% w/v (intradermal induction) and 3, 6, 12.5, and 25% w/v (topical induction). Although the effects induced by intradermal injection of the test concentrations were not indicated, the intradermal induction dose was determined to be 1% w/v.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal (3 sites) and topical)
- Exposure period: 48 hours for the topical induction
- Test groups: 1 test group of 20 males.
- Control group: 2 control groups of 10 males each.
- Site:
For the intradermal induction: Starting at the back of the neck, three intradermal injections were given parallel to each flank. The intervals between the injection sites were approx. 1- 2 cm.
For the topical induction: placed between or on the injection sites
- Concentrations: 1% Pencycuron in the intradermal induction, and 25% Pencycuron for the topical induction.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 but observed up to 48 hours after exposure.
- Exposure period: 24 hours
- Test groups: 1 test group of 20 males.
- Control group: 1 control group of 10 males each.
- Site: on the left flank of the animals
- Concentrations: 25% Pencycuron.
- Evaluation (hr after challenge): 24 and 48
Challenge controls:
A hypoallergenic dressing soaked in the formulation vehicle was placed on the left flank of the animals in the first control group, and fastened to the skin with occlusive tape for 24 hours.
For comparison a similar control dressing was fastened to the right flank, and this had only been soaked with the formulation vehicle.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not reported

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle control
Dose level:
0%
No. with + reactions:
1
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:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Remarks:
The incidence of animals with positive dermal reactions (10%) is marginally higher than the incidence of reactions to the vehicle (5%) and is not indicative of skin sensitisation.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Remarks:
The incidence of animals with positive dermal reactions (10%) is marginally higher than the incidence of reactions to the vehicle (5%) and is not indicative of skin sensitisation.
Reading:
other: No details reported
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Pencycuron is not sensitising to the skin of guinea pigs in this Maximisation test.
Executive summary:

Pencycuron was investigated for possible skin-allergising potential with a sensitisation test on male guinea pigs (MAGNUSSON and KLIGMAN's maximisation test). Pilot tests to establish the dose indicated that the following concentrations of the test compound should be used in the study:


intradermal induction: 1 %
topical induction: 25 %
challenge: 25 %


After the challenge one animal in the test compound group reacted positively according to the evaluation criteria, while the animals in the control group did not exhibit any alterations. The degree of intensity of the response in this animal was only slight. The reaction observed in the skin of one animal is not significant, as experience has shown that individual animals can react spontaneously in this way.


The results therefore indicate that the test compound does not have a skin-sensitising effect on guinea pigs.