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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
(2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride
EC Number:
278-860-3
EC Name:
(2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride
Cas Number:
78182-00-0
Molecular formula:
C7H18NO2.Cl
IUPAC Name:
3-hydroxy-N-(2-hydroxyethyl)-N,N-dimethylpropan-1-aminium chloride
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