Registration Dossier
Registration Dossier
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EC number: 629-661-9 | CAS number: 83834-59-7
Endpoint summary
Administrative data
Description of key information
- Skin irritation
not irritating (Fed. Reg. 38, No. 187, section 1500.41, p. 27019, Sept. 27, 1973).
- Eye irritation
not irritating (J.H. Kay et col., in vivo Test de Draize, J.Soc.Cos.Chem. 13/281, 1962).
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study, deviations to current testing protocols
- Qualifier:
- according to guideline
- Guideline:
- other: FED. REG. 38, NO. 187, SECTION 1500.41 P. 27019, SEPT. 27, 1973
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; D-6050 Offenbach/Main, Germany
- Weight at study initiation: 2,45; 2.46; 2.89; 2.88; 3.21; 2.98 (kg)
- Housing: cage made of stainless steel with wire mesh walk floors, floor area: 40 cm X 51 cm, No. of animals per cage: 1; No bedding in the cages; Sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study: same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 - 18.00 h/18.00 - 6.00 h)
IN-LIFE DATES: From: 28.01.1985 To: 12.02.1985 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipping of fur
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL of test substance on a 2.5 cm X 2.5 cm patch - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 30 - 60 min, 24 h, 48 h, 72 h, 8 d, 15 d
- Number of animals:
- 6 (5 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
EVALUATION OF ERYTHEMA AND EDEMA:
0 = NONE
1 = YERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Scaling observed in 1/6 animals, fully reversible within 15 days
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
| Readings | Animal | Erythema | Edema | Further findings |
| 24 h | 1 | 2 | 1 | |
| 2 | 2 | 0 | ||
| 3 | 2 | 1 | ||
| 4 | 2 | 1 | R:E | |
| 5 | 2 | 0 | ||
| 6 | 2 | 1 | ||
| 48 h | 1 | 1 | 0 | |
| 2 | 1 | 0 | ||
| 3 | 2 | 0 | ||
| 4 | 2 | 0 | R:E | |
| 5 | 1 | 0 | ||
| 6 | 2 | 0 | ||
| 72 h | 1 | 1 | 0 | |
| 2 | 1 | 0 | ||
| 3 | 2 | 0 | ||
| 4 | 2 | 0 | R:E | |
| 5 | 1 | 0 | ||
| 6 | 2 | 0 | ||
| 8 d | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 1 | 0 | S | |
| 5 | 1 | 0 | ||
| 6 | 0 | 0 | ||
| 15 d | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| Mean (24 h - 72 h) | 1 | 1.3 | 0.3 | |
| 2 | 1.3 | 0.0 | ||
| 3 | 2.0 | 0.3 | ||
| 4 | 2.0 | 0.3 | ||
| 5 | 1.3 | 0.0 | ||
| 6 | 2.0 | 0.3 | ||
| Mean (24 h - 72 h) | all animals | 1.7 | 0.2 |
R:E = Erythema, extending beyond the area of exposure S = Scaling. Similar findings after application on abraded skin with mean (24 h - 72 h) erythema/edema score (all animals): 1.7/0.3 (not relevant for assessment). Findings 30 - 60 min after patch removal were not reported.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- april 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was not conducted according to an OECD Test Guideline. Acceptable data.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- according to ref.: J.H. Kay et col., J.Soc.Cos.Chem. 13/281, 1962
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- Group I - 168 hours (not rinsed)
Group II - 2 seconds (rinsed)
Group III - 4 seconds (rinsed) - Observation period (in vivo):
- 168 hours (at 1, 24, 48, 72, 96 and 168 hours)
- Number of animals or in vitro replicates:
- Group I - 3
Group II - 3
Group III - 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group I: not rinsed; Group II: rinsed with water after 2 sec.; Group III: rinsed with water after 4 sec.
- Time after start of exposure: 2 sec. and 4 sec.
SCORING SYSTEM: according to ref.: J.H. Kay et col., J.Soc.Cos.Chem. 13/281, 1962 - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Overall score from all groups
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: overall score from all groups
- Irritant / corrosive response data:
- A slight irritation of the conjunctivae was observed during the few hours after application of pure 2-Ethylhexyl 4-methoxycinnamate. This irritation is manifested by the presence of some more capillaries injected into the eye treated than on the eye not treated. No effect could be detected 24 hours after application of the test substance. No effect of rinsing was observed.
No effects on cornea and iris were observed. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No effects on eye irritation could be detected 24 hours after application of 2-Ethylhexyl 4-methoxycinnamate. Based on these results, 2-Ethylhexyl 4-methoxycinnamate does not need to be classified as irritating according to the criteria outlined in regulation 1272/2008/EC.
- Executive summary:
2-Ethylhexyl 4-methoxycinnamate had been injected into the left eye of 3 albino rabbits without rinsing, the left eye of another 3 albino rabbits were rinsed after 2 and 4 seconds, resp. Cornea, iris, and conjunctivae were examined. A slight irritation of the conjunctivae was observed during the few hours after application of pure 2-Ethylhexyl 4-methoxycinnamate. This irritation is manifested by the presence of some more capillaries injected into the eye treated than on the eye not treated. No effect, however small, could be detected 24 hours after application of the test substance. Based on these results, 2-Ethylhexyl 4-methoxycinnamate does not need to be classified as irritating according to the criteria outlined in regulation 1272/2008/EC.
Referenceopen allclose all
ObservationTime |
Animal nr. |
Group I Conjunctivae |
Group II Conjunctivae |
Group III Conjunctivae |
Results |
1 hour |
1 |
A2 |
A1 |
A2 |
3.3 |
1 hour |
2 |
A1 |
A2 |
A1 |
|
1 hour |
3 |
A2 |
A2 |
A2 |
|
24 hours |
1 |
|
|
|
0 |
24 hours |
2 |
|
|
|
|
24 hours |
3 |
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion potential of Ethylhexyl Methoxycinnamate was studied in white rabbits according to Fed. Reg. 38, No. 187, section 1500.41, p. 27019, Sept. 27, 1973 (BASF AG, 1985). Taking into consideration the stringent application conditions in the key study, i.e. 24 hours occlusive, only slight irritative potential of the test compound has been found. The findings do not fulfil the criteria as skin irritant according to regulation 1272/2008/EC (CLP/EU-GHS).
The primary eye irritation potential of Ethylhexyl Methoxycinnamate was studied according to the in vivo Test de Draize (ref.: J.H. Kay et col., J.Soc.Cos.Chem. 13/281, 1962) in albino rabbits (Dufour, 1971). The results of this study do not fulfil the criteria as eye irritant according to regulation 1272/2008/EC (CLP/EU-GHS).
Justification for classification or non-classification
Both the key study and supporting studies indicate that Ethylhexyl Methoxycinnamate does not induce significant or irreversible damage to the rabbit skin and eye. Therefore, it can be concluded that the substance is not irritating and therefore does not need to be classified as such according to the criteria outlined in 1272/2008/EC (CLP/EU-GHS).
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