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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD guideline 406.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
This substance has been demonstrated to be a non-sensitizer in a guideline compliant studies, therefore potency data as generated in an LLNA is not needed.
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: no data
- Weight at study initiation: 300-400 g
- Housing: under standard laboratory conditions (max. 5 animals per metallic cage: bottom 2544 cm2 and 38 cm height)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Humidity (%): 40-80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Irritation Screen: 100%, 50%, 10% and 5%
Induction: 80%
Challenge: 40%
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Irritation Screen: 100%, 50%, 10% and 5%
Induction: 80%
Challenge: 40%
No. of animals per dose:
20 test animals & 10 control animals
Details on study design:
RANGE FINDING TESTS: Irritation screen with 5%, 10%, 50% and100%.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Site: dorsal surface
- Frequency of applications: 3
- Concentrations: 80%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 hours
- Site: dorsal surface
- Concentrations: 40%
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Morbidity/Mortality: All subjects survived treatment with the test compound. 
Clinical signs: None reported. No dermal effects reported at site of application. 
Body weights: No effect on body weights reported. Macroscopic Examinations: No gross lesions recorded. Induction reactions and duration: No effects reported.

Challenge reactions and duration: At the 24-hour reading, all scores in treated animals were 0 for erythema or edema.
Scores remained 0 at the 48-hour reading.

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
PnB did not cause contact hypersensitivity under the conditions of this test.
Classification: not sensitizing
Executive summary:

Propylene glycol n-butyl ether (DOWANOL*PnB) was tested for skin sensitization in guinea pigs by a modified Buehler test procedure. A volume of 0.3 ml of a freshly prepared solution of DOWANOL PnB in propylene glycol (p.g.) was applied on a patch to the clipped area of the skin. The patch appliance was occluded with a rubber dental dam making snug contact with the animal over the entire dorsal surface, during 6 hours. The readings were carried out after 24 and 48 hours.

The primary irritation screen indicated that an 80% solution of DOWANOL PnB in p.g. could be used for the final study. Ten male and ten female guinea pigs were treated once a week for 3 weeks. After the last induction exposure, the animals were left untreated for approximately two weeks before primary challenge. This challenge was carried out with a 40% solution of DOWANOL PnB in p.g.. Neither the test groups nor the ten animals in the control group produced a significant reaction. Under the experimental conditions used, DOWANOL PnB did not induce contact hypersensitivity in guinea pigs.

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

Propylene glycol n-butyl ether was tested for skin sensitization in guinea pigs by a modified Buehler test procedure.

The primary irritation screen indicated that an 80% solution of Propylene glycol n-butyl ether

in propylene glycol could be used for the final study. Ten male and ten female guinea pigs were treated once a week for 3 weeks. After the last induction exposure, the animals were left untreated for approximately two weeks before primary challenge. This challenge was carried out with a 40% solution of propylene glycol n-butyl ether in propylene glycol. Neither the test groups nor the ten animals in the control group produced a significant reaction. Under the experimental conditions used, propylene glycol n-butyl ether did not induce contact hypersensitivity in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Based on the absence of skin sensitising potential, genotoxicity and irritancy, propylene glycol n-butyl ether is not expected to be a respiratory tract sensitiser.


Justification for classification or non-classification

Propylene Glycol n-Butyl Ether did not induce contact hypersensitivity in guinea pigs. None of the twenty animals showed a reaction, post challenge 24 and 48 hours after exposure. According to EU criteria for classification and labelling requirements for dangerous substances as laid down in Annex VI to the EEC Council Directive 67/548 EEC (amended by Directive 83/467 EEC), Propylene Glycol n-Butyl Ether will not be classified for skin and respiratory sensitization.