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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 14 day observation period followed and hence, no reversibility of the effect was assessed; this deviation is not considered to compromise the result, the study is considered acceptable. Animals were immobilized in a canvas body sleeve during treatment
Principles of method if other than guideline:
no 14 day observation period followed and hence, no reversibility of the effect was assessed; this deviation is not considered to compromise the result, the study is considered acceptable. Animals were immobilized in a canvas body sleeve during treatment
GLP compliance:
no
Remarks:
Study performed prior to GLP adoption

Test material

Constituent 1
Reference substance name:
Cypress, Cupressus funebris, ext.
EC Number:
285-360-9
EC Name:
Cypress, Cupressus funebris, ext.
Cas Number:
85085-29-6
Molecular formula:
Not applicable due to UVCB nature of the substance
IUPAC Name:
Essential oil of Cedarwood obtained from the wood of Cupressus funebris (Cupressaceae) by steam distillation
Test material form:
not specified
Details on test material:
For specific details on test material if available - See in RSS
- Name of test material (as cited in study report): Cedarwood oil Chinese
- Lot/batch No.: No data
- Purity: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 w
Animals in telogen phase of hair growth are selected.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
4, 24, 48 and 72 h
Number of animals:
8
Details on study design:
POSITIVE CONTROLS: yes, animals treated with diethyl phthalate (100%), cyclamen aldehyde (100%), geraniol (100%) (standards for comparison)

TEST SITE
Occlusive patches prepared by heat-sealing 1x1 24 ply gauze pads on to 1 (1/4) X 1 (1/4) squares of polythene sheeting . attached to 3 X (1/2) X 1 strips.
Animals are immobilized in a canvas body sleeve during treatment. The test susbstance was applied on the dorsal skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, wiped clean
- Time after start of exposure: 4 h
The application site is examined immediately (4h) and at 24, 48 and 72 h after treatment.

SCORING SYSTEM: 8 point anchored ordinate scale ranging from 'a' (very slight) to 'h' (severe). Wilcoxon Matched-Pairs Signed Ranks Test. See sextion 'any other information on materials and methods incl. tables' for details.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
2.67
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean 24, 48, 72 h
Score:
2.33
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal: 7
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal: 8
Time point:
other: mean 24, 48, 72 h
Score:
2.67
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean 24, 48, 72 h
Score:
2.67
Irritation parameter:
edema score
Basis:
animal: 7
Time point:
other: mean 24, 48, 72 h
Score:
3
Irritation parameter:
edema score
Basis:
animal: 8
Time point:
other: mean 24, 48, 72 h
Score:
2.67
Irritant / corrosive response data:
The test substance produced moderate to severe erythema and moderate edema. Fairly well developed suspected necrosis was seen in 3 animals at 24 h, still visible 72 h post-treatment. The observed necrosis warrants a classification for corrosion, it was observed at 24 h post treatment. Therefore, the test substance is considered to be corrosive to the skin and can be subclassified as Cat. 1C/H314, according to the classification criteria of Annex I of 1272/2008/EC (CLP). Necrosis was not detected in animals treated with the positive controls cyclame aldehyde and geraniol, and erythema/edema were more pronounced in test substance treated animals.

Any other information on results incl. tables

Table 1. Converted irritation scorings

erythema

Animal #

24 hours

48 hours

72 hours

AVG

1

3

3

3

3.00

2

3

2

3

2.67

3

3

3

3

3.00

4

3

3

3

3.00

5

3

2

2

2.33

6

3

3

3

3.00

7

3

3

3

3.00

8

3

2

3

2.67

oedema

Animal #

24 hours

48 hours

72 hours

AVG

1

3

3

3

3.00

2

3

3

3

3.00

3

3

3

3

3.00

4

3

3

3

3.00

5

3

3

3

3.00

6

3

2

3

2.67

7

3

3

3

3.00

8

3

2

3

2.67

Applicant's summary and conclusion

Interpretation of results:
other: skin corrosive
Remarks:
Based on CLP criteria
Conclusions:
Under the conditions of this study, the mean scores observed in the animals would lead to a classification for skin irritation. However, necrosis was observed in 3 animals, 24 hours after the 4 hour exposure period. Therefore, Cedarwood Chinese oil is considered corrosive to the skin of New Zealand rabbit, and shall be classified for skin corrosion (Skin Corr. 1C / H314) according to the criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

In this acute dermal irritation study (similar to OECD 404) the test substance Cedarwood Chinese was applied at a volume of 0.5 ml on the dorsal skin, clipped free of fur, of New Zeland White rabbits. The materials were held in contact with the skin under a semi-occlusive dressing for a 4 h period after which the patches were removed. Skin reaction to the material was assessed immediately, at 24, 48 and 72 h after dosing. Diethyl phthalate, cyclamen aldehyde, and geraniol were used as standards for comparison.

At 24 h after dosing, well-defined erythema and oedema were observed in most animals, that persisted at 72 h post-treatment and very slight to well-defined erythema was apparent in two animals. The mean scores for erythema (24, 48, 72 h) were in the range of 2.3 to 3.0, and for edema in the range of 2.67 to 3.0. Fairly well developed suspected necrosis was seen in 3 animals at 24 h, still visible 72 h post-treatment. Necrosis was not detected in animals treated with the positive controls cyclame aldehyde and geraniol, and erythema/edema was more pronounced in test substance treated animals.

It was concluded that under the conditions of this test, the substance needs to be classified as corrosive to the skin (Skin Corr. 1C / H314) according to the criteria laid down in Annex I of 1272/2008/EC (CLP).