Registration Dossier
Registration Dossier
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EC number: 285-360-9 | CAS number: 85085-29-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cupressus funebris, Cupressaceae.
Endpoint summary
Administrative data
Description of key information
Skin Irritation (similar to OECD 404) : corrosive
Eye Irritation (similar to OECD 405) : not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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. - 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. - 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.
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-10-16 until 1978-10-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted similar to OECD guideline 405 (2002). The study was not conducted according to GLP as it was performed prior to its adoption.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No systemic analgesic was applied pretreatment, nor was appropriate topical anesthesia given. In addition not all animals were observed for three full days.
- Principles of method if other than guideline:
- No systemic analgesic was applied pretreatment, nor was appropriate topical anesthesia given. In addition not all animals were observed for three full days.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Age at study initiation: 7-9 weeks
- Weight at study initiation: 1-2 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- After applying the product to the rabbits eyes, the irritation reaction is examined 15 minutes later. Subsequently the eyes are monitored at daily intervals untill the treated eyes are considered to be of normal appearance.
- Observation period (in vivo):
- immedeate, 15 minutes, 24 hours, 48 hours, 72 hours (last timepoint for one rabbit only)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No data
SCORING SYSTEM:
The numerical scorings recorded were made differed to a certain extent from the grading scheme of OECD guideline 405. Both grading schemes score ocular lesions (corneal, iridic and conjunctival irritation), but the grading differed (see Table X in attached document).
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- The ocular reactions observed during the study remained slight to moderate and only recorded at the conjunctivae level: all animals had slight conjunctivitis but this was healed on day 3. In addition two animals had turgid swelling in the upper cheek area after 4 hours of treatment. This was no longer evident on day 1.
- Other effects:
- The authors conclude that the test compound, Cedarwood Chinese, is a slight eye irritant, according to the method they used (Modified Federal Hazardous Substance Labelling Act Method).
- Interpretation of results:
- other: not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- In an eye irritation study performed similar to OECD405, Cedarwood Chinese oil did not induce significant or irreversible damage to the rabbit eye. Under the conditions of this test, Cedarwood Chinese oil does not need to be classified for eye irritant in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
- Executive summary:
The primary eye irritation potential of Cedarwood Chinese oil was investigated with a test method similar to OECD TG 405 (2002). The test item was applied (0.1 mL undiluted) to one eye of in total 3 New Zealand White rabbits. Eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and also at daily intervals with a slit lamp, also corneal swelling was measured. The test substance caused a slight opacity, affecting up to 1/2 of the cornea in one animal. All the animals had slight conjunctivitis. All three animals had healed by day three. Two animals had turgid swelling in the upper cheek area, 4 hrs after treatment, which was not evident anymore on day 1. To be able to interpret the results, the grading scheme as used in the study report was converted to the current OECD TG 405 grading scale. After conversion, the mean scores for corneal opacity and iritis were 0, for conjunctival redness in the range of 0.3-0.6, and for conjunctival chemosis in the range of 0-0.3. Based on the results of this test, it was concluded that Cedarwood Chinese oil does not need to be classified for eye irritant in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
Reference
It is noted that the 72 -hour reading point is not available, but given the slight effect observed it is not expected that this would change the study outcome. The calculations, as presented in the tabel in the result section, are based on an average of three days. If there was no data for day 3, it was assumed that the score for this day should be 0 (also because in all cases the day before the score was also 0).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
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. Based on these results, the substance can be regarded corrosive to the skin.
Eye irritation
The primary eye irritation potential of Cedarwood Chinese oil was investigated with a test method similar to OECD TG 405 (2002). The test item was applied (0.1 mL undiluted) to one eye of in total 3 New Zealand White rabbits. Eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and also at daily intervals with a slit lamp, also corneal swelling was measured. The test substance caused a slight opacity, affecting up to 1/2 of the cornea in one animal. All the animals had slight conjunctivitis. All three animals had healed by day three. Two animals had turgid swelling in the upper cheek area, 4 hrs after treatment, which was not evident anymore on day 1. To be able to interpret the results, the grading scheme as used in the study report was converted to the current OECD TG 405 grading scale. After conversion, the mean scores for corneal opacity and iritis were 0, for conjunctival redness in the range of 0.3-0.6, and for conjunctival chemosis in the range of 0-0.3. Based on these results, Cedarwood Chinese oil is not considered to be an eye irritant.
Justification for classification or non-classification
Based on the available data, Cedarwood Chinese oil needs to be classified for skin corrosion (Skin Corr. 1C / H314) in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
In addition, Cedarwood Chinese oil did not induce significant or irreversible damage to the rabbit eye and therefore does not need to be classified for eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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