Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03/1987-04/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: Clear liquid.
Administered as: Undiluted liquid.
Specific Gravity: 0.88 g/ml.
Solubility: 6% in water.
Stability: Stable up to 200°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 1953, 1872 and 1933 g
- Housing: individually housed in plastic cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 45-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left flank
-coverage: 6 cm2
- Type of wrap if used: gauze patch attached to aluminium foil and mounted on permeable tape


REMOVAL OF TEST SUBSTANCE
Exposure duration was 4 hours after which the remaining test substance was removed using a dry tissues and subsequently a tissue moistened with tap-water.

SCORING SYSTEM:
see other information on materials and methods below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all animals
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
3
Irritant / corrosive response data:
From the first day on, one of the animals had an extensive area of the treated skin with eschar formation. This had disappeared on day 14, except for a small corner of the exposed skin site which showed signs of chronic dermal inflammation. On the skin of the other two rabbits well defined erythema and slight edema were observed, with some scaliness during days 2 and 3. This had disappeared on day 14 when the study was terminated.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to EU criteria the undiluted PnB should be classified as a skin irritant based on the mean erythema score >= 2 for all animals.
Executive summary:

In a primary dermal irritation/corrosivity test, 0.5 milliliters of undiluted propylene glycol n-butyl ether was applied to a 6 x 6 cm square area of clipped, unabraded skin on the left flank of three young adult female New Zealand white rabbits. The test material was held in contact with the skin for a period of 4 hours under a semi-occlusive dressing. After this period, the dressing and test material were removed by washing with tissues and water.  The site of application was evaluated for irritation by scoring 1) erythema/eschar and 2) edema. Both criteria were scored on a scale of 0 - 4 at approximately 30 minutes after removal of the test material, and at 24, 48, and 72 hours, and on
days 7 and 14. One subject had eschar over a large portion of the treated site, which did not completely disappear by day 14. This subject also exhibited chronic dermal irritation on day 14. The remaining two subjects showed well-defined erythema and slight edema with scaliness (days 2 and 3) that
disappeared over the 14 day observation period.
The mean erythema score was >=2 for all animals.