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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1997-11-11 to 1997-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-carbaldehyde
EC Number:
214-333-6
EC Name:
Pyridine-2-carbaldehyde
Cas Number:
1121-60-4
Molecular formula:
C6H5NO
IUPAC Name:
pyridine-2-carbaldehyde
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.60 - 2.69kg
- Housing: individual
- Diet (e.g. ad libitum): STANRAB SQC Rabbit diet, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21°C
- Humidity (%): 46 - 66%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
Duration of treatment / exposure:
three exposure durations: 3 min; 1 h; 4 h
Observation period:
1, 24, 48 and 72h and 7 and 14 days after removal of the patch
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5cm
- Type of wrap if used: surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 min; 1 h; 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72h and 7 and 14 days after removal of the patch

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
exposure: 4h
Basis:
mean
Time point:
24/48/72 h
Score:
1.22
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: observation after 72h on two animals not possible because of adverse skin reaction
Irritation parameter:
edema score
Remarks:
exposure: 4h
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: observation after 72h on two animals not possible because of adverse skin reaction
Irritation parameter:
edema score
Remarks:
exposure: 1h
Basis:
mean
Time point:
24/48/72 h
Score:
0.94
Max. score:
4
Reversibility:
other: observation after 7 and 14 days on two animals not possible because of adverse skin reaction
Irritation parameter:
erythema score
Remarks:
exposure: 3min
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
exposure: 3min
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
Other adverse local effects:
Green coloured dermal necrosis over whole treatment site occured
- in 2 of 3 animals after 4h-exposure for at least 48h. Afterwards observation was not possible because of adverse skin reaction.
- in 2 of 3 animals after 1-h-exposure for at least 72h. Afterwards observation was not possible because of adverse skin reaction.
- in 0 of 3 animals after 3-min-exposure.

Any other information on results incl. tables

4h exposure
observation time
animal nr   24h 48h 72h
I erythema 2 2 2
edema 2 2 2
II erythema 4 4 *
edema 3 2 *
III erythema 4 4 *
edema 3 2 *

* = observation not possible because of adverse skin reaction

1h exposure
observation time
animal nr   24h 48h 72h
I erythema 2 2 2
edema 1 1 1
II erythema 4 4 4
edema 3 2 2
III erythema 4 4 4
edema 3 2 2

3min exposure
observation time
animal nr   24h 48h 72h
I erythema 1 1 0
edema 0 0 0
II erythema 1 1 0
edema 0 0 0
III erythema 1 1 0
edema 0 0 0

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The test material caused necrosis after 4-h-exposure and after 1-h-exposure. The effects were not reversible. The test item caused no skin reaction after 3-min-exposure.
Therefore the test item is classified as Skin corrosiv category 1B based on GHS data.