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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
16 April 1996 to 19 April 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Although conducted by a test method and following good laboratory procedures of the US FDA, there were several inconsistencies noted. The study protocol was not approved by the Sponsor prior to conduct of the study. The Study Director did not sign the study protocol. The study was not inspected by the Quality Assurance Unit during the progress of the study. The study was not conducted for sufficient time to determine reversibility of effects, although, after 72 hours effects observed were only minimal to mild. The dates of study conduct and final signed report dates differ by nearly 2 years.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Federal Hazardous Substance Act, 16 CFR 1500.41
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
deviations: the study protocol was not approved by the Sponsor or signed by the Study Director; the study was not inspected by the Quality Assurance Unit during it progress.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
431-090-3
EC Name:
-
Cas Number:
190085-41-7
Molecular formula:
C19 H30 O3
IUPAC Name:
2-butyloctyl 2-hydroxybenzoate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A USDA licensed supplier
- Age at study initiation: not supplied
- Weight at study initiation: not supplied
- Housing: Animals were randomly assigned to cages on arrival and were housed individually in suspended stainless steel cages, six cages to a unit, in an environmentally controlled room.
- Diet (ad libitum): Agway Prolab High Fiber 5P25 Rabbit feed, alfalfa cubes
- Water (ad libitum): city tap water
- Acclimation period: at least 4 days prior to the start of testing

IN-LIFE DATES: From: 16 April 1996 To: 19 April 1996

Test system

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The sample was dosed by volume (0.5 ml) as received with a sterile syringe.
Duration of treatment / exposure:
24 hours
Observation period:
The skin was graded for dermal irritation at 24 and 72 hours after administration.
Number of animals:
6
Details on study design:
Site Preparation
Animals were clipped free of fur at the test site with Oster(TM) electric clippers. On the right side of the test site a 21 gauge needle was used to make three 2-3 cm long longitudinal abrasions through the stratum corneum but not so deep as to disturb the dermal or cause bleeding (abraded). The left side was left intact.

Application
The test substance was applied to both intact and abraded skin, and each area was covered with a 1 inch square gauze patch. The entire area was covered with plastic wrap and over-wrapped with Elastikon tape to ensure contact of the test substance with the skin and to prevent ingestion of the test substance.

The skin was exposed for a period of 24 hours after which the patch and any residual material was removed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 and 72h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72h
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks:
48h observation not performed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
72h

Any other information on results incl. tables

Primary Rabbit Skin Irritation Scores

Erythema & Eschar Formation  Reading(Hours)  Rabbit No.1  2  3  4  5  6  Average
 Intact Skin  24 2  1  2  2  2  2  1.83
   72  1  1  1F  1F  1  1  1.00
 Abraded Skin  24  2  2  2  2B  2  2  2.00
   72  1  1  2F  2F  1  1  1.33
Subtotal                 6.16

B = Blanching       F = Flaking

Edema Formation  Reading(Hours)  Rabbit No.1  2  3  4  5  6  Average
 Intact Skin  24 1  0  1  1 1   1  0.86
   72 0   0  0  0  0  0  0
 Abraded Skin  24 1   1  1  2  1  1  1.17
   72  0  0  1  1  0  0  0.33
Subtotal                 2.33

Primary Irritation Score = (6.16 + 2.33) / 4 = 8.49 / 4 = 2.12

Applicant's summary and conclusion

Interpretation of results:
other: Not a primary dermal irritant
Remarks:
Criteria used for interpretation of results: other: US Federal Hazardous Substances Act 16 CFR 1500.3(c)(4)
Conclusions:
The test material would not be considered a primary dermal irritant as defined by the Federal Hazardous Substance Act 16 CFR 1500.3 (c) (4) because it did not induce skin reactions with a primary irritation score of 5 or greater.

The test material is not irritating to intact skin according to the EU Directive 67/548/EEC as mean scores for either erythema and eschar formation or edema for intact skin either averaged over all animals or individually did not equal or exceed 2. No labeling is required.

The test material is not classified according to GHS criteria based on mean overall erythema and eschar formation scores for intact skin of
Executive summary:

The test article, C.P. Hall Company's sample of RX-13643, lot B.N. YZH012396, was dosed as supplied in accordance with the method described in the Federal Hazardous Substance Act (USA) 16 CFR 1500.41. It produced very slight to well-defined erythema and very slight to well-defined edema. One animal had blanched skin at a test site; two animals had flaking skin. The Primary Irritation Score was 2.12.