Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1999-02-23 to 1999-07-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted on 17 July, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-pyridyl dimethylcarbamate
EC Number:
257-297-7
EC Name:
3-pyridyl dimethylcarbamate
Cas Number:
51581-32-9
Molecular formula:
C8H10N2O2
IUPAC Name:
pyridin-3-yl N,N-dimethylcarbamate
Specific details on test material used for the study:
- CAS No. : 51581-32-9
- Batch No.: TMFP 304
- Purity: At least 99 %
- Solubility in water: soluble
- Storage: in the refrigerator, in the dark
- Date of expiry: December 1999
- Appearance: Colorless liquid
pH: 7.29

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: J. Schitkovits, A-2620 Natschbach
- Weight (at study initiation and termination) : Animal no. 1: 2.9 kg and 3.1 kg, Animal no. 2: 2.7 kg and 2.9 kg, Animal 3: 2.8 kg and 2.8 kg
- Housing: Individual caging in metal wire cages
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 53
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm

OBSERVATION TIME POINTS : 1, 24, 48 and 72 h
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: Scoring terms of 24, 48 and 72 h after the patch removal were used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
All areas treated with the test substance and all control areas were normal before the application and at each observation time
Other effects:
- Other adverse local effects: None
- Other adverse systemic effects: None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, the test substance is considered non-corrosive or a non-irritant to the skin.
Executive summary:

In an in vivo skin irritation study conducted according to the OECD guideline 404, 0.5 mL of the test item was spread on cellulose patches in a size of about 2.5 cm X 2.5 cm and were applied to test sites on each of 3 New Zealand White rabbits for 4 hours. The patches were then removed and the skin was examined for erythema / eschar and oedema as well as other local signs approximately 1, 24, 48 and 72 hours after patch removal. No general toxic effects were observed. All areas treated with test substance and all control areas were normal before the application and at each observation time. Based on these results, the test substance is considered as a non-irritant to the skin under the UN GHS Criteria.