Registration Dossier

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:
08.04.1999-01.09.1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
other: EC Directive No. 92/69/EEC, B.6, 31st July 1992
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA test has not been conducted because adequate data from a Guinea pig maximization test (report date 1999) were already available (study scientifically not necessary - other informarion available)
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals
Species and sex: male and female guinea-pigs.
Strain and sanitary status: Hartley Cri: (HA) BR, Caesarian obtained, Barrier sustained - Virus
Antibody Free (COBS - VAF@). .
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
The strain used has been shown to produce a satisfactory sensitization response using known
positive sensitizers.
Breeder: Charles River France, 76410 Saint-Aubin-Ies-Elbeuf, France.
Number: . one male and one female for the preliminary test, .30 animals (15 males and 15 females) for the main test.
Females were nulliparous and non-pregnant.
Allocation of the animals to the groups: on day -1, the animals were weighed and randomly
allocated to two groups: a control group 1 consisting of ten animals (five males and
five females) and a treated group 2 consisting of 20 animals (ten males and ten females).
Weight: on day 1, the animals of the main test were approximately 3 months old and had a mean
body weight ± standard deviation of 349 ± 10 g for the males and 345 ± 13 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: ear-tattoo.

Environmental conditions
The conditions in the animal room were set as follows:
• temperature: 21 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 hl12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records
were checked daily and filed. In addition to these daily checks, the housing conditions and
corresponding instrumentation and equipment are verified and calibrated at regular intervals.
During the acclimatization period and throughout the study, the animals were housed
individually in polycarbonate cages (48 cm x 27 cm x 20 cm) equipped with a polypropylene
bottle.
Dust-free sawdust was provided as litter (SICSA, 92142 Alfortville, France).
Bacteriological and chemical analyses of the sawdust, including the detection of possible
contaminants (pesticides, heavy metals), are performed regularly by external laboratories.
The results of these analyses are archived at CIT.

Food and water
During the study, the animals had free access to "106 pelleted diet" (UAR, 91360 Villemoissonsur Orge, France).
Food is analysed regularly by the supplier for composition and contaminant levels.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by external laboratories.

No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Remarks:
A homogenous solution was obtained at the maximum concentration on 75 % (w/w)
Concentration / amount:
Induction (treated group)
- intrademal injections: Butyldigylcol methacrylate at the concentration
of 25% (w/w) in corn oil,
. topical application: Butyldigylcol methacrylate undiluted.
Challenge (all groups)
. topical application: Butyldigylcol methacrylate undiluted.
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Remarks:
A homogenous solution was obtained at the maximum concentration on 75 % (w/w)
Concentration / amount:
Induction (treated group)
- intrademal injections: Butyldigylcol methacrylate at the concentration
of 25% (w/w) in corn oil,
. topical application: Butyldigylcol methacrylate undiluted.
Challenge (all groups)
. topical application: Butyldigylcol methacrylate undiluted.
No. of animals per dose:
Thirty guinea-pigs were allocated to two groups: a control group 1 (five males and five females) and a treated group 2 (ten males and ten females).
Positive control substance(s):
yes
Remarks:
2,4-Dinitro chlorobenzene (DNCB)
Positive control results:
The species and strain which were used showed satisfactory sensitization response in 90 % animals treated with DNCB.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 % 2,4-Dinitro chlorobenzene (DNCB)
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1 % 2,4-Dinitro chlorobenzene (DNCB)
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Control Group

Sex

Animal

No.

24 h

48 h

 

 

Erythema

Oedema

Erythema

Oedema

 

 

LF

RF

LF

RF

LF

RF

LF

RF

Male

91

0

0

0

0

0

0

0

0

 

92

0

0

0

0

0

0

0

0

 

93

0

0

0

0

0

0

0

0

 

94

0

0

0

0

0

0

0

0

 

95

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

Female

106

0

0

0

0

0

0

0

0

 

107

0

0

0

0

0

0

0

0

 

108

0

0

0

0

0

0

0

0

 

109

0

0

0

0

0

0

0

0

 

110

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

Treated Group

Sex

Animal

No.

24 h

48 h

 

 

Erythema

Oedema

Erythema

Oedema

 

 

LF

RF

LF

RF

LF

RF

LF

RF

Male

96

0

0

0

0

0

0

0

0

 

97

0

0

0

0

0

0

0

0

 

98

0

0

0

0

0

0

0

0

 

99

0

0

0

0

0

0

0

0

 

100

0

0

0

0

0

0

0

0

 

101

0

0

0

0

0

0

0

0

 

102

0

0

0

0

0

0

0

0

 

103

0

0

0

0

0

0

0

0

 

104

0

0

0

0

0

0

0

0

 

105

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

Female

111

0

0

0

0

0

0

0

0

 

112

0

0

0

0

0

0

0

0

 

113

0

0

0

0

0

0

0

0

 

114

0

0

0

0

0

0

0

0

 

115

0

0

0

0

0

0

0

0

 

116

0

0

0

0

0

0

0

0

 

117

0

0

0

0

0

0

0

0

 

118

0

0

0

0

0

0

0

0

 

119

0

0

0

0

0

0

0

0

 

120

0

0

0

0

0

0

0

0

LF : left flank (vehicle)

RF :right flank (undiluted test substance)

No cutaneous reactions were observed.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Butyldiglycol methacrylate is not considered to be a skin sensitizer.
Executive summary:

In a guinea pig maximization test acc. OECD guideline 406 with 10 male and 10 female Hartley Crl guinea pigs no clinical signs or death were noted during the study and no cutaneous reactions were observed after the challenge application.

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, Butyldiglycol methacrylate does not induce delayed contact hypersensitivity in guinea-pigs. Butyldiglycol methacrylate is not considered to be a skin sensitizer and is not classified under EU criteria.

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

One relevant, reliable (Klimisch score 1; reliable without restrictions) study is available for the sensitising potential of BDGMA. 

In a dermal sensitisation study with BDGMA, 10 female and 10 male Hartley Cri. Guinea Pigs were tested using the method of Magnusson & Kligman (Guinea Pig Maximisation Test) Control group: 5 males and 5 females. In a pretest, BDGMA was shown to be not irritating.

Induction (treated group)

- intradermal injections: Butyldigylcol methacrylate at the concentration of 25% (w/w) in corn oil,

. topical application: Butyldigylcol methacrylate undiluted.

Challenge (all groups)

. topical application: Butyldigylcol methacrylate undiluted.

 

Positive control: 2,4-Dinitro chlorobenzene (DNCB)

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, Butyldiglycol methacrylate does not induce delayed contact hypersensitivity in guinea-pigs. Butyldiglycol methacrylate is not considered to be a skin sensitizer.


Migrated from Short description of key information:
One relevant, reliable (Klimisch score = 1) and adequate study is available.

Justification for selection of skin sensitisation endpoint:
Guideline study OECD 406, GLP

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Inhalation is no relevant route of exposure.

Justification for classification or non-classification

There are currently no conclusive indications for a classification of BDGMA as skin sensitiser according to regulation (EC) 1272/2008 and the former European directive on classification and labelling 67/548/EEC.