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EC number: 810-519-1 | CAS number: 1648784-10-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 7 June 2014 and 15 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- NACET10419
- IUPAC Name:
- NACET10419
- Reference substance name:
- (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
- IUPAC Name:
- (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
- Reference substance name:
- 1450841-11-8 (planar)
- IUPAC Name:
- 1450841-11-8 (planar)
- Test material form:
- other: liquid
- Details on test material:
- Identification: NACET10419
Common/Commercial name: NACET10419
Chemical name: (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
CAS number: 1450841-11-8 (planar)
EC number: not allocated
Batch: KU31213
Purity: 100%
Physical state / Appearance: clear colorless liquid
Expiry date: 20 December 2015
Storage Conditions: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.66 or 2.89 kg and were twelve to twenty weeks old. After an acclimatization period of at least five days each animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A quantity of 0.5 mL of the test item was applied directly to the skin
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- On the day before the test two rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
After consideration of the skin reactions produced in the first animal, an additional animal was treated with 0.5 mL of test item. One patch was applied to the back of the rabbit and was allowed to remain in contact with the skin for a period of four hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 74393 male
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 74454 male
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Erythema extended up to 10 cm beyond test site and moderate desquamation observed
- Irritation parameter:
- edema score
- Basis:
- animal: 74393 male
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 74454 male
- Time point:
- other: Highest score at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Edema extended ventrally below the test site
- Irritant / corrosive response data:
- 3-Minute Exposure Period
The individual scores for erythema/eschar and edema are given in Table 1.
Very slight erythema and very slight edema were noted at the treated skin site immediately and 1 hour after patch removal. The treated skin site appeared normal at the 24 Hour observation.
1-Hour Exposure Period
The individual scores for erythema/eschar and edema are given in Table 1.
Very slight erythema and very slight edema were noted at the treated skin site immediately, 1 and 24 hours after patch removal with very slight erythema noted at the 48 and 72 Hour observations. The treated skin site appeared normal at the 7 Day observation.
4-Hour Exposure Period
The individual scores for erythema/eschar and edema are given in Table 2. The individual mean scores are given in Table 3.
Well defined erythema and slight edema were noted at both treated skin sites immediately, 1 and 24 hours after patch removal with well defined erythema and very slight or slight edema noted at the 48 and 72 Hour observations. The erythema extended up to 10 cm and the edema extended ventrally below the test site of one animal immediately and 1 hour after patch removal. Extension of erythema alone persisted at the test site of this animal 24 hours after patch removal.
Moderate desquamation was noted at one treated skin site at the 7 Day observation.
One treated skin site appeared normal at the 7 Day observation and the other treated skin site appeared normal at the 14 Day observation. - Other effects:
- Body weight
Individual body weights and body weight change are given in Table 4.
Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 1 Individual Skin Reactions Following 3-Minute and 1-Hour Exposures
Skin Reaction |
Observation Time |
Individual Scores |
|
Rabbit Number and Sex |
|||
74393 Male |
|||
3-Minute Exposure |
1-Hour Exposure |
||
Erythema/Eschar Formation |
Immediately |
1 |
1 |
1 Hour |
1 |
1 |
|
24 Hours |
0 |
1 |
|
48 Hours |
0 |
1 |
|
72 Hours |
0 |
1 |
|
7 Days |
0 |
0 |
|
Edema Formation |
Immediately |
1 |
1 |
1 Hour |
1 |
1 |
|
24 Hours |
0 |
1 |
|
48 Hours |
0 |
0 |
|
72 Hours |
0 |
0 |
|
7 Days |
0 |
0 |
Table2 Individual Skin Reactions Following 4-Hour Exposure
Skin Reaction |
Observation Time |
Individual Scores |
Total |
|
Rabbit Number and Sex |
||||
74393 Male |
74454 Male |
|||
Erythema/Eschar Formation |
Immediately |
2 |
2R |
(4 ) |
1 Hour |
2 |
2R |
( 4 ) |
|
24 Hours |
2 |
2R |
4 |
|
48 Hours |
2 |
2 |
( 4 ) |
|
72 Hours |
2 |
2 |
4 |
|
7 Days |
0 |
0D |
( 0 ) |
|
14 Days |
- |
0 |
( 0 ) |
|
Edema Formation |
Immediately |
2 |
2Ed |
( 4 ) |
1 Hour |
2 |
2Ed |
( 4 ) |
|
24 Hours |
2 |
2 |
4 |
|
48 Hours |
1 |
2 |
( 3 ) |
|
72 Hours |
1 |
2 |
3 |
|
7 Days |
0 |
0 |
( 0 ) |
|
14 Days |
- |
0 |
( 0 ) |
|
Sum of 24 and 72‑Hour Readings (S) : 15 |
||||
Primary Irritation Index (S/4) : 15/4 = 3.8 |
||||
Classification : MODERATE IRRITANT |
( ) = Total values not used for calculation of primary irritation index
R = Erythema extended up to 10 cm beyond test site
Ed = Edema extended ventrally below the test site
D = Moderate desquamation
- = Not applicable
Table3 Individual and Mean Scores for Skin Reactions Following 4-Hour Exposure
Skin Reaction |
Reading (Hours) |
Individual Scores – Rabbit Number and Sex |
|
74393 Male |
74454 Male |
||
Erythema/Eschar Formation |
24 |
2 |
2 |
48 |
2 |
2 |
|
72 |
2 |
2 |
|
Total |
6 |
6 |
|
Mean Score |
2.0+ |
2.0+ |
|
Edema Formation |
24 |
2 |
2 |
48 |
1 |
2 |
|
72 |
1 |
2 |
|
Total |
4 |
6 |
|
Mean Score |
1.3 |
2.0+ |
+= Positive criterion according tothe Globally Harmonized System of Classification and Labelling of Chemicals leading to GHS category 3 ‘mild irritant’
Table 4 Individual Body Weights and Body Weight Change
Rabbit Number |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
74393 |
Day 0 |
Day 7 |
0.22 |
2.66 |
2.88 |
||
74454 |
Day 0 |
Day 14 |
0.47 |
2.89 |
3.36 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test item produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
The test item was also classified as Category 3 (Mild irritant) according to the Globally Harmonized System of Classification and Labelling of Chemicals. - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item following single, 3‑Minute, 1 and 4‑Hour, semi‑occluded applications to the intact rabbit skin.
Results
3‑Minute and 1‑Hour semi-occluded applications of the test item to the intact skin of one rabbit produced very slight erythema and very slight edema.
A single 4‑Hour, semi occluded application of the test item to the intact skin of two rabbits produced well‑defined erythema, slight edema and moderate desquamation. One treated skin site appeared normal at the 7‑Day observation and the other treated skin site appeared normal at the 14‑Day observation.
Conclusion
The test item produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
The test item was also classified as Category 3 (Mild irritant) according to the Globally Harmonized System of Classification and Labelling of Chemicals.
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