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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Two rabbits were exposed to the test substance for 5 minutes, 1 hour and 2 hours under occlusive conditions. The animals were observed for 8 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butan-1-ol
EC Number:
200-751-6
EC Name:
Butan-1-ol
Cas Number:
71-36-3
Molecular formula:
C4H10O
IUPAC Name:
butan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
product No. 03331, 78/305

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.97 - 3.4 kg


ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
5 minutes, 1 hour and 2 hours
Observation period:
8 days
Number of animals:
two animals per exposure period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
exposure for 2 hours
Time point:
other: 24/48/72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: superficial necrosis
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
exposure for 2 hours
Time point:
other: 24/ 48/ 72 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: superficial necrosis
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
exposure for 2 hours
Time point:
other: 24/48/ 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: edema extending beyond the area of exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
exposure for 2 hours
Time point:
other: 24/ 48/ 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: extending beyond the area of exposure
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
exposure for 1 hour
Time point:
other: 24/48 hours
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: scaling
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
exposure for 1 hour
Time point:
other: 24/48 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: bloody crust, superficial necrosis
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
exposure for 1 hour
Time point:
other: 24/48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
exposure for 1 hour
Time point:
other: 24/ 48 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
exposure for 5 min
Time point:
other: 24/48/ 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
exposure for 5 min
Time point:
other: 24/ 48/ 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
exposure for 5 min
Time point:
other: 24/48/ 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
exposure for 5 min
Time point:
other: 24/48/ 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d

Any other information on results incl. tables

Exposure for 2 hours under occlusive conditions led to superficial necrosis. No full thickness destruction of the skin occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria