Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well conducted study similar to guideline (no GLP; TS purity not specified; TS applied as 80% aqueous preparation, occlusive application, 8 days observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
TS applied as 80% aqueous preparation, occlusive application, 8 days observation period
GLP compliance:
no
Remarks:
well documented study with quality controlled data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Dimethylaminopropanol + 1 EO Hydrochlorid
- Physical state: solid
No additional details provided

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler (company); 6050 Offenbach / Main
- Weight at study initiation: mean body weight of 3.17 kg (3.15 and 3.18 kg) for the 2 males, 2.93 kg for the female
- Clipping of the fur: at least 15 hours before study start
- Housing: one rabbit per cage (stainless steel; area 40 x 51 cm, no bedding)
- Diet (e.g. ad libitum): Ovator Solikanin 4 MM diet (about 130 g per animal and day) from Muskator-Werke, 4000 Duesseldorf
- Water (e.g. ad libitum): drinking water (daily about 250 ml per animal)
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated site skin of the same animal
Amount / concentration applied:
about 0.5 g (test patch with 0.5 mm thick film of the 80% test substance preparation)
Duration of treatment / exposure:
4 hours
Observation period:
up to 8 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flank region
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize, 1959
Reading times: 30 - 60 min after removal of the test patches as well as 24 hours, 48 hours and 8 d after application. Because a slight irritation reaction present after 24 hours in one animal was completely reversible within 48 hours, no 72-reading was made.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: mean 24-48 hour
Score:
0.15
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: a slight erythema (score 1) was present in 1 animals after 24 hours, but was completely reversible within 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean 24-48-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema was observed at any time point
Irritant / corrosive response data:
No irritation reaction was observed at the end of the observation period (8 days after treatment).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information