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Registration Dossier
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EC number: 248-469-2 | CAS number: 27458-92-0
Endpoint summary
Administrative data
Description of key information
- skin:
rabbit, 4 h, semiocclusive: irritant (BASF, 2003, OECD 404, GLP)
rabbit, 1-15 min, 20 h, occlusive: irritant (BASF, 1963)
in vitro EpiDerm Skin Corrosivity Test: not corrosive (BASF, 2003, GLP)
- eye:
rabbit, OECD 405: not irritant (BASF, 2003)
rabbit, BASF-test: not irritant (BASF, 1963)
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Dec. 29, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan IVIAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 7 - 8 months
- Weight at study initiation: 3.89 - 4.18 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day )
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3 (2 female and 1 male animal)
- Details on study design:
- TEST SITE
- Area of exposure:flank (the test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the undiluted liquid test substance)
- % coverage:
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol E 400 (Polyethylenglycol) and Lutrol/water (1 : 1)
- Time after start of exposure: 4 h
SCORING SYSTEM: according to Draize / OECD 404
EVALUATION OF RESULTS:
For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.
ILLUMINATION USED FOR READING: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
CHECK FOR DEAD OR MORIBUND ANIMALS: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- (within the observation period of 14 days)
- Remarks on result:
- other: Scaling at the end of the observation period in 3 animals (see table below for details).
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- in 2 animals after 24 h, in 1 animal after 14 days
- Remarks on result:
- other: Scaling at the end of the observation period in 3 animals (see table below for details).
- Irritant / corrosive response data:
- Moderate erythema (grade 2), observed in all animals immediately and 1 hour after removal of the patch, increased to marked (grade 3) after 24 hours and persisted up to 72 hours in all animals and up to day 7 in one animal. Marked erythema decreased to moderate in two animals on day 7 and to slight (grade 1) in all animals after 14 days (study termination). Slight or moderate edema (grade 1 or 2) was noted in all animals immediately and 1 hour after removal of the patch. Slight edema persisted in 1 animal up to day 7. Additionally erythema and edema were partly extended beyond the area of exposure.
Moreover scaling, partly extending beyond the area of exposure, severe scaling as well as petechiae, both extending beyond the area of exposure and thickening of the skin in the region of the application area were noted during the observation period.
The cutaneous reactions (such as slight erythema) were not reversible in all animals within study termination on day 14. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Reference
| Exposition: | 4 h (semiocclusive) | |||
| Animal | Reading | Erythema | Edema | Comments |
| 1 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
| 2 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
| 3 | 0 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
| 1 | 1 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
| 2 | 1 h | 2 | 2 | Erythema/Edema extending beyond the area of exposure |
| 3 | 1 h | 2 | 1 | Erythema/Edema extending beyond the area of exposure |
| 1 | 24 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 2 | 24 h | 3 | 1 | Erythema/Edema extending beyond the area of exposure |
| 3 | 24 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 1 | 48 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 2 | 48 h | 3 | 1 | Erythema/Edema extending beyond the area of exposure |
| 3 | 48 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 1 | 72 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 2 | 72 h | 3 | 1 | Erythema/Edema/Petechiae extending beyond the area of exposure |
| 3 | 72 h | 3 | 0 | Erythema extending beyond the area of exposure |
| 1 | 7 days | 2 | 0 | Scaling |
| 2 | 7 days | 3 | 1 | Erythema/Edema/Severe Scaling extending beyond the area of exposure |
| 3 | 7 days | 2 | 0 | Erythema/Scaling extending beyond the area of exposure |
| 1 | 14 days | 1 | 0 | Scaling |
| 2 | 14 days | 1 | 0 | Erythema/Scaling extending beyond the area of exposure, Thickening of the skin in the region of the application area |
| 3 | 14 days | 1 | 0 | Erythema/Scaling extending beyond the area of exposure |
| mean (animal 1) | 24 - 72 h | 3 | 0 | |
| mean (animal 2) | 24 - 72 h | 3 | 1 | |
| mean (animal 3) | 24 - 72 h | 3 | 0 | |
| mean (animal 1-3) | 24 - 72 h | 3.00 | 0.33 | |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 4 months
- Weight at study initiation: 3.07 - 3.20 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 h (2 animals), 7 days (1 animal)
- Number of animals or in vitro replicates:
- 3 (2 females and 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h
SCORING SYSTEM: according to OECD 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: cornea opacity (score 1) only observed in one animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h - 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: chemosis (score 1) observed in 3 animals
- Irritant / corrosive response data:
- Moderate conjunctival redness (grade 2), slight conjunctival chemosis (grade 1) and moderate to severe discharge (grade 2 - 3), were observed in all animals 1 hour after application.
Slight conjunctival redness (grade 1) was noted in 1 animal 24 and 48 hours after application. Moderate conjunctival redness (grade 2) was observed in 2 animals 24 hours after application and decreased to slight conjunctival redness (grade 1) after 48 hours after application. In one of these two animals slight conjunctival redness persisted up to 72 hours after application. Additionally slight corneal opacity (grade 1) and loss of corneal tissue was noted in this animal 48 and 72 hours after application.
The ocular reactions were reversible in 2 animals after 72 hours and in 1 animal within 7 days after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0 .7 and 0 .0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.7, 1.3 and 1.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.
INDIVIDUAL OCULAR EXAMINATIONS AND MEAN VALUES
Readings Animal Cornea Iris Conjuntiva Additional Findings
Opacity Area of Redness Chemosis Discharge
cornea
involved
-------------------------------------------------------------------------------------------------------------------
1h 1 0 0 0 2 1 2
1h 2 0 0 0 2 1 3
1h 3 0 0 0 2 1 2
-------------------------------------------------------------------------------------------------------------------
24h 1 0 0 0 1 0 0
24h 2 0 0 0 2 0 0
24h 3 0 0 0 2 0 0
-------------------------------------------------------------------------------------------------------------------
48h 1 0 0 0 1 0 0
48h 2 1 1 0 1 0 0 LC
48h 3 0 0 0 1 0 0
-------------------------------------------------------------------------------------------------------------------
72h 1 0 0 0 0 0 0 SD
72h 2 1 1 0 1 0 0 LC
72h 3 0 0 0 0 0 0 SD
-------------------------------------------------------------------------------------------------------------------
7d 2 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------
Mean 1 0.0 0.0 0.7 0.0
Mean 2 0.7 0.0 1.3 0.0
Mean 3 0.0 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------
Mean 0.2 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------
Explanation of findings:
LC = Loss of corneal tissue
SD = Study discontinued because the animal was free of findings - Interpretation of results:
- GHS criteria not met
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only 50µl used instead of 100µl
- Principles of method if other than guideline:
- BASF-Test: 50 µl of the test substance were applied to the conjunctival sac of one eye of 2 White Vienna rabbits. The eyes were not washed out after 24 h and the observation period was 8 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, NaCl
- Duration of treatment / exposure:
- see: observation period: no washing out conducted
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-2)
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: conjuntivae redness (score 1) 1 h after administration in both animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-2)
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: chemosis (score 1) only observed in 1 animal 1 h after administration
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
Referenceopen allclose all
| Animal | Reading | Conjunctivae Redness |
Chemosis |
| 1 | 1 h | 1 | 0 |
| 2 | 1 h | 1 | 1 |
| 1 | 24 h | 0 | 0 |
| 2 | 24 h | 0 | 0 |
| 1 | 8 d | 0 | 0 |
| 2 | 8 d | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Irritation to skin was analyzed in a reliable GLP-study conducted according to OECD 404 (BASF, 2003). 0.5 ml of undiluted iso-tridecan-1-ol (> 99%) was administered to the skin of 3 New Zealand White rabbits for 4 h under semi occlusive conditions. The mean scores (24 - 48 -72 h) for erythema and edema were 3 and 0.3, respectively. Within 14 days, erythema scores decreased to 1, but did not reverse completely. Edemas were reversible (within 24 h in 2 animals and within 7 days in 1 animal). Additionally, scale formation at the end of the observation period was observed.
A second study (BASF, 1963), which was conducted before the implementation of GLP and OECD Guidelines, confirmed the irritant potential of the test substance. 2 rabbits per group were exposed to 0.5 g test substance under occlusive conditions for 1, 5, or 15 min, or for 24h. Regardless of exposure time, at most slight edema (grade 1) and moderate erythema (mean values of 2.5 – 2.75) were observed. 20 hours occlusive exposure also led to superficial necrosis. Effects were reversible within 8 days, though scaling remained.
Additionally, an in vitro EpiDerm Skin Corrosivity Test was conducted (BASF, 2003; according to OECD 431) with Isotridecanol H (> 99%). Based on the observed results it was concluded, that the test substance does not show a corrosive potential. Irritant effects cannot be excluded by this in vitro test.
Open application of 0.01 mL of undiluted Tridecanol caused skin irriation grade 4 on a scale of 1-10, maximum value in 5 rabbits (Smyth, 1962), while secondary sources report no skin irritation in rats or rabbits, if the test substance is applied openly (BIBRA 1988, OECD SIDS, 2006).
Eye irritation
Irritation to eyes was analyzed in a reliable GLP-study conducted according to OECD 405 (BASF, 2003). Three New Zealand White rabbits received a single instillation of 0.1 ml of the undiluted test substance. After 24 h the test substance was removed with tap water. The mean cornea, iris, conjunctivae and chemosis scores (24 – 48 – 72 h) were 0.2, 0, 1 and 0, respectively. All effects were reversible within 7 days.
The findings of an additional study (BASF, 1963) confirm these results. The lower amount of 50µL of Tridecanol caused only slight conjunctival redness and chemosis after 1h in 2 animals, but no signs of irritation after 24h.
Smyth et al. 1962 also reported only a slight irritant potential of grade 2 on a scale of 1-10, which means that 500µL (five times the amount required by current guidelines) of undiluted test substance did not cause severe injury (1-5 points on a scale of 0-20).
Justification for classification or non-classification
Classification for skin irritation is based on the OECD guideline study, which results in classification as a skin irritant cat. 2 according to 1272/2008/EC (CLP). All remaining studies (except for open applications of an unknown amount) support this conclusion.
The results reported for eye irritation do not meet the classification criteria according to 1272/2008/EC (CLP).
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