Registration Dossier
Registration Dossier
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EC number: 225-878-4 | CAS number: 5131-66-8
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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.
Test material
- Reference substance name:
- 1-butoxypropan-2-ol
- EC Number:
- 225-878-4
- EC Name:
- 1-butoxypropan-2-ol
- Cas Number:
- 5131-66-8
- Molecular formula:
- C7H16O2
- IUPAC Name:
- 1-butoxypropan-2-ol
- Details on test material:
- Identity: Dowanol-PnB (1-butoxy-2-hydroxypropane or
propylene glycol normal-butyl ether). CAS # 29387-86-8 (also
5131-66-8)
Batch No.: XZ 95410.00.
Purity: "More than 98%"*.
Supplied as: Not reported.
Appearance: Transparent fluid.
Administered as: Various dilutions (see below).
Specific Gravity: 0.88 g/ml.*
Solubility: 6% in water.*
Stability: Stable up to 200°C.*
* from acute oral toxicity report for PnB that used same
sample lot
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Irritation Screen: 100%, 50%, 10% and 5%
Induction: 80%
Challenge: 40%
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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 chemical
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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