Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-076-0 | CAS number: 2623-23-6
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Jun - 11 Jun 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatliches Gewerbeaufsichtsamt, Hildesheim, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 1.06, 2.13, 4.25, 8.50 and 17 mg/L
- Sampling method: Samples were analysed from freshly prepared media after 0, 24, 48 and 72 hours and from corresponding aged test media after 24, 48, 72 and 96 hours.
- Sample storage conditions before analysis: All samples were stored at 6 ± 2 °C until start of analysis, if necessary. Prepared samples were stored at room temperature until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Appropriate volumes of the test item were pipetted directly into the test vessels filled with appropriate volumes of the dilution water. Test media were mixed with an ultraturrax (2 min at 8500 rpm). The test vessels were covered with a floating lid. After a settling period of 2 h the fish were inserted. This procedure was repeated for each renewal day.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium conrol
- Evidence of undissolved material: no, test solutions were clear - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Length at study initiation: 2.53 cm (mean)
- Weight at study initiation: 0.141 g (mean)
ACCLIMATION
- Acclimation period: at least 12 d
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Sera Vipan, Sera GmbH, Heinsberg, Germany
- Feeding frequency during acclimation: 3 time a week (4% of the fish body weight per feeding day); not fed 24 h before study initiation
- Health during acclimation: No mortality was observed during this time. No disease treatments were administered throughout holding and testing.
FEEDING DURING TEST
- None - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 59 mg/L as CaCO3
- Test temperature:
- 22.9 - 23.9 °C (mean: 23.3 °C ± 0.3 °C)
- pH:
- 6.97 - 7.57
- Dissolved oxygen:
- 86 - 100% O2 saturation
- Nominal and measured concentrations:
- nominal: control, 1.06, 2.13, 4.25, 8.50 and 17 mg/L
geometric mean measured: < LOQ, 0.301, 0.462, 1.26, 3.10, 9.30 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquaria
- Type (delete if not applicable): covered with a floating lid
- Material, size, headspace, fill volume: Glass, 13 L (25.5/18/28 cm), headspace: 3 L, fill volume: 10 L
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.099 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water of local origin
- Hardness: 10 - 250 mg CaCO3/L
- Conductivity: 168 µS/cm
- Acidity: 0.10 mmol/L
- Acid capacity: 0.60 mmol/L
- Culture medium different from test medium: same as test
- Intervals of water quality measurement: pH-value, temperature and oxygen saturation were measured in all test vessels at the beginning and at the end of the exposure and every 24 h from fresh and old test media. Water temperature was recorded once per hour with a data logger. Light intensity was measured on the water surface at test start.
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 h light / 8 h darkness
- Light intensity: 7 - 750 lux
EFFECT PARAMETERS MEASURED
- Mortality was recorded after 2, 24, 48, 72 and 96 h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: control, 17 mg/L
- Results used to determine the conditions for the definitive study: 100% mortality was recorded after 24 h at the limit concentration. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 6.72 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI
- Remarks:
- 3.10 - 9.30 mg/L
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 3.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 9.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: Up to a concentration of 3.1 mg/L all fish behaved normal. At the highest test concentration surviving fish were observed to be lethargic, staggering, on a side position and/or missing escape reflex.
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no, test solutions were clear - Reported statistics and error estimates:
- LC50 value was calculated by linear regression.
- Sublethal observations / clinical signs:
Table 1: Cumulative mortality
Geometric mean measured test item concentrations [mg/L]
Cumulative mortality [%] during the study [h]
2
24
48
72
96
9.30
0
0
29
71
71
3.10
0
0
0
0
0
1.26
0
0
0
0
0
0.452
0
0
0
0
0
0.301
0
0
0
0
0
Control
0
0
0
0
0
Table 2: Measured concentrations of the test substance
Nominal concentration
0 h (fresh)
24 h (old)
24 (fresh)
48 h (old)
48 h (fresh)
72 h (old)
72 h (fresh)
96 h (old)
Geometric mean [mg/L]
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
17
11.8
69
9.10
54
14.6
86
11.2
66
9.85
58
9.26
54
5.05
30
6.91
41
9.30
8.5
4.97
58
3.23
38
2.58
30
2.13
25
3.68
43
2.55
30
3.29
39
3.15
37
3.10
4.25
2.56
60
1.23
29
1.53
36
1.09
26
1.17
28
0.810
19
1.24
29
1.01
24
1.26
2.13
0.833
39
0.345
16
0.827
39
0.480
23
0.291
14
0.187
9
0.584
27
0.477
22
0.452
1.06
0.587
55
0.231
22
0.371
35
0.157
15
0.498
47
0.296
28
0.256
24
0.223
21
0.301
Control
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
Table 3: Measured concentrations of the metabolite
Nominal concentration
0 h (fresh)
24 h (old)
24 (fresh)
48 h (old)
48 h (fresh)
72 h (old)
72 h (fresh)
96 h (old)
Geometric mean [mg/L]
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
Meas. [mg/L]
%
17
< LOQ
<1
0.790
6
0.0397
<1
0.599
5
0.0425
<1
0.619
5
0.0383
<1
0.142
1
0.203
8.5
0.0955
1
1.06
16
0.00953
<1
0.349
5
0.0434
<1
0.684
10
0.0192
<1
0.285
4
0.157
4.25
0.00393
<1
0.236
7
0.0166
<1
0.157
5
0.0122
<1
0.214
6
0.0128
<1
0.170
5
0.0787
2.13
< LOQ
<1
0.150
9
0.0222
1
0.199
12
0.00546
<1
0.102
6
0.0101
<1
0.130
8
0.0460
1.06
0.00836
1
0.0786
9
0.0214
3
0.1253
15
0.00791
1
0.0998
12
0.00999
1
0.0792
10
0.0406
Control
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
- Validity criteria fulfilled:
- yes
- Conclusions:
- This short-term study with fish resulted in a LC50 (96 h) of 6.72 mg/L (geom. mean measured concentration).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 13 Jul - 17 Jul 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- No details were provided.
- Vehicle:
- no
- Details on test solutions:
- The test item was pestled in a mortar, weighed into water and centrifuged in an Ultra-Turrax to create the test solutions. At all concentrations tested, a certain amount of the test item remained undissolved and was floating on the surface of the test solutions. Therefore, the actual test concentrations were measured daily using gas chromatography.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Common name: Brachydanio rerio
Date of birth: 1992-04-18
Date of shipment: 1992-06-10
Length at study initiation: 2.5 - 3.5 cm
Mortalita during acclimatisation: <2%
Medical pretreatment: None
Water for acclimatisation: Synthetic freshwater (according to ISO) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 14.1 °dH
- Test temperature:
- 21.4 - 22.5 °C; A small decrease in test temperatures during the study period (about 1 °C in most cases) was observed in most of the experiments.
- pH:
- 7.1 - 8.0
- Dissolved oxygen:
- 8.1 - 10.4 mg/L (O2 saturation: 93.4 - 120.0%)
- Nominal and measured concentrations:
- nominal: control, 7.8, 11, 16, 22, and 31 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: test aquaria with 300 x 135 x 200 mm, containing 5 L test medium
- Aeration: Yes
TEST MEDIUM / WATER PARAMETERS
- Dilution water: Synthetic freshwater (ISO)
- Controls: Synthetic freshwater (ISO)
- Solubilizing aid: Treatment with an Ultra-Turrax
OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h darkness per day
EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
Assesessed during the experiment at 0, 24, 48, 72, and 96 h:
- Abiotic parameters: Temperature (°C), dissolved oxygen (mg/L), oxygen saturation (% ), pH
- Outer appearance and behaviour of the test animals
- Mortality
Assesessed after death during the experiment or sacrification after termination of the experiment:
- Body weight and length of the test animals
TEST CONCENTRATIONS
- Nominal test concentrations: 7.8, 11, 16, 22, and 31 mg/L
- Actual test concentrations were measured daily using gas chromatography - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 13.2 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 15.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: as geom. mean of LC0 and LC100 as determined
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 18.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- dissolved
- Basis for effect:
- mortality (fish)
- Sublethal observations / clinical signs:
Table 1 Abiotic parameters
Control
Time (h)
0
24
48
72
96
Temperature (°C)
21.5
21.4
21.1
21.1
21.0
Dissolved oxygen (mg/L)
8.6
8.3
9.4
8.1
9.9
Oxygen saturation (%)
99.9
96.3
108.4
93.4
114.1
pH
7.9
7.8
7.1
7.7
7.7
at 7.8 mg/L
Time (h)
0
24
48
72
96
Temperature (°C)
22.3
21.4
21.1
21.1
21.2
Dissolved oxygen (mg/L)
8.7
8.4
10.2
8.7
8.8
Oxygen saturation (%)
102.5
97.4
117.6
100.3
101.7
pH
7.9
7.5
7.4
7.3
7.4
at 11 mg/L
Time (h)
0
24
48
72
96
Temperature (°C)
22.4
21.5
21.1
21.1
21.3
Dissolved oxygen (mg/L)
8.6
8.5
10.4
8.8
8.7
Oxygen saturation (%)
101.5
98.7
120.0
101.5
100.7
pH
8.0
7.5
7.6
7.3
7.5
at 16 mg/L
Time (h)
0
24
48
72
96
Temperature (°C)
22.3
21.5
21.2
21.1
21.4
Dissolved oxygen (mg/L)
8.6
8.6
10.3
8.7
8.5
Oxygen saturation (%)
101.3
99.9
119.1
100.3
98.6
pH
7.9
7.6
7.4
7.4
7.5
at 22 mg/L
Time (h)
0
24
48
72
96
Temperature (°C)
22.5
21.5
21.2
21.2
NA
Dissolved oxygen (mg/L)
8.5
8.7
10.6
8.9
NA
Oxygen saturation (%)
100.5
101.0
122.5
102.9
NA
pH
7.8
7.6
7.7
7.6
NA
at 31 mg/L
Time (h)
0
24
48
72
96
Temperature (°C)
22.4
21.3
NA
NA
NA
Dissolved oxygen (mg/L)
8.4
8.4
NA
NA
NA
Oxygen saturation (%)
99.2
97.2
NA
NA
NA
NA = not assessed
Table 2. Mortality
No mortality within 96 h was observed in control animals and at concentrations of the test item of 7.8, 11, and 16 mg/L.
At 22 mg/L
Time (h)
2
24
48
72
96
absolute number of deaths
0
5
0
5
NA
cumulative number of deaths
0
5
5
10
NA
cumulative number of deaths (%)
0
50
50
100
NA
at 31 mg/L
Time (h)
2
24
48
72
96
absolute number of deaths
10
NA
NA
NA
NA
cumulative number of deaths
10
NA
NA
NA
NA
cumulative number of deaths (%)
100
NA
NA
NA
NA
NA = not assessed
Table 3: Outer appearance and behaviour
at 11 mg/L
after 2 h
10 animals
Sluggish swimming
after 24 h
10 animals
Sluggish swimming
after 48 h
10 animals
Sluggish swimming
after 72 h
10 animals
Sluggish swimming
at 16 mg/L
after 2 h
10 animals
Sluggish swimming
after 24 h
10 animals
Sluggish swimming
after 48 h
8 animals
Sluggish, lethargic swimming
2 animals
Sluggish, lethargic swimming, abnormal posture
after 72 h
8 animals
Sluggish, lethargic swimming
2 animals
Sluggish, lethargic swimming, abnormal posture
after 96 h
10 animals
Sluggish, lethargic swimming
at 22 mg/L
after 2 h
10 animals
Akinetic, uncontrolled swimming movements upon touching
after 24 h
5 animals
Akinetic, uncontrolled swimming movements upon touching
after 48 h
5 animals
Akinetic, uncontrolled swimming movements upon touching
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this short-term toxicity test in Brachydanio rerio, the non-lethal concentration 0% (LC0) and the lethal concentration 100% (LC100) were determined as 13.2 and 18.4 mg/L, respectively. The geometric mean between both values (LC50) was calculated as 15.6 mg/L.
- Executive summary:
The short-term toxicity of the test item, Menthol H&R Komp., was assessed in a test in Brachydanio rerio. The test was conducted according to the EU method No. C.1. The test animals were exposed to the test at concentrations of the test item 7.8, 11, 16, 22, and 31 mg/L for up to 96 h and were observed for mortality as well as for changes in their outer appearance and behaviour. Body weight and length of the fish were also recorded. From the mortality data obtained in this study, values for the lethal concentration 0% (LC0) and the lethal concentration 100% (LC100) were determined as 13.2 and 18.4 mg/L, respectively. The geometric mean between both values was calculated as 15.6 mg/L.
Referenceopen allclose all
Description of key information
LC50 (96 h) = 6.72 mg/L (measured, OECD 203); read-across
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 6.72 mg/L
Additional information
Since no data for the target substance (L-menthyl acetate, CAS 2623-23-6) are available, the aquatic toxicity is assessed on the basis of data from one structurally similar substance (menthyl acetate, CAS 89-48-5) and a possible product of hydrolysis (L-menthol,CAS 2216-51-5). A detailed justification of the analogue approach is provided in the overall summary and in the technical dossier in IUCLID Section 13.
The key study with the source substance menthyl acetate was
conducted according to OECD 203 (GLP). Danio rerio was exposed to
nominal concentrations of 1.06, 2.13, 4.25, 8.50 and 17 mg/L for 96 h
under semi-static conditions. The exposure concentrations were verified
by GC/MS analysis. Measurements indicate that the measured
concentrations did not remain within 80-120% of nominal. The recovery
rate ranged from 14 - 86% in the freshly prepared media and 9 - 66% in
the aged test solutions. Thus, the effect concentrations were based on
the geometric mean of measured concentrations. After 96 h an LC50 of
6.72 mg/L was calculated by regression analysis.
The
supporting study with L-menthol, performed according to EU Method C.1
(GLP), resulted in a slightly higher LC50 (96 h) of 15.6 mg/L (measured).
Based on the results from one structurally related source substance and the expected hydrolysis product (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that L-menthyl acetate has toxic effects on freshwater fish.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.