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EC number: 208-686-5 | CAS number: 538-23-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Oral (OECD 422, read across): NOAEL rat, fertility = 1000 mg/kg bw/day
Oral (OECD 422, read across): NOAEL rat, systemic toxicity = 1000 mg/kg bw/day
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- parental fertility
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects
- Remarks on result:
- other:
- Remarks:
- Source: CAS 91052-13-0
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- development
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
- Remarks on result:
- other:
- Remarks:
- Source: CAS 91052-13-0
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their reproduction toxicity potential. The available data from the source substance glycerides, C8-18 and C18-unsatd. mono- and di-,acetates (CAS 91052-13-0) obtained in a screening study conducted according to OECD guideline 422 showed no adverse effects on reproduction parameters in parental rats and their F1 offspring. Therefore, no reproduction toxicity is expected for the target substance glycerol trioctanoate (CAS 538-23-8).
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises an adequate and reliable (Klimisch score 2) study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, eco-toxicological and toxicological profile (refer to the endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Justification for read across
There are no data on the reproduction toxicity of glycerol trioctanoate (CAS 538-23-8). The assessment was therefore based on studies conducted with analogue substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Toxicity to reproduction
CAS 91052-13-0
An oral gavage screening toxicity study was performed according to OECD guideline 422 and under conditions of GLP in Crl:WI(Han) Wistar rats at doses of 0, 100, 300 and 1000 mg/kg bw/day (key, 2010). Dilutions of the test substance in polyethylene glycol were administered once daily to groups of 10 male and 5 female rats (main animals) via gavage. A control group received the vehicle. In addition, satellite groups of 5 males and 5 females (recovery animals) each for the control and high dose group were used to investigate reversibility of effects during a 14-day post-exposure recovery period. Furthermore, 10 females (repro animals) were added to each group for the assessment of reproduction and developmental toxicity. Main and recovery animals were exposed for at least 28 days from start of treatment up to termination or start of recovery. Females used for the assessment of reproduction/developmental toxicity were exposed for 41-49 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. In parental animals, no effects on reproductive function (spermatogenetic and oestrus cycle) and performance (mating, fertility and conception indices, precoital time, and number of corpora lutea and implantation sites) were observed after treatment compared to controls. Testis weight, epididymis weight, and histology of testes in males as well as histology of uterus epithelium in female did not reveal any substance-related effects in the parental animals. No toxicologically relevant alterations in offspring viability indices were observed. Therefore, a NOAEL for parental fertility of 1000 mg/kg bw/day was derived for male and female Crl:WI(Han) Wistar rats.
Overall conclusion for effects on fertility
There are no available studies on the toxicity to reproduction and fertility of glycerol trioctanoate (CAS 538-23-8). Therefore analogue read-across from a source substance was applied. The potential for reproductive toxicity of the source substances was assessed in reproductive/developmental screening studies (OECD 422). The NOAEL value for fertility was 1000 mg/kg bw/day. Therefore, no hazard to reproduction was identified. Based on the available data and following the analogue approach, the target substance of glycerol trioctanoate (CAS 538-23-8) is not expected to affect fertility.
Effects on developmental toxicity
Description of key information
Oral (teratogenicity study): NOAEL rabbit, developmental = 2862 mg/kg bw/day
Oral (teratogenicity study): NOAEL mouse, developmental = 9540 mg/kg bw/day
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No soft tissue and head examinations were performed in foetuses.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A teratogenicity study in mice was conducted in 1970, prior to any OECD guideline adoption.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: ICR-JCL
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-8 weeks
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-60 - Route of administration:
- oral: gavage
- Vehicle:
- other: 1.2% Tween 80/0.8% Span 80 in water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was mixed with 1.2% (w/v)Tween 80 and 0.8% (w/v) Span 80 in water. The emulsion was prepared with Manton Gaulin Homgenizer.
VEHICLE
- Justification for use and choice of vehicle: low water solubility - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- No detailed information is available.
- Duration of treatment / exposure:
- Day 7-12 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Day 18 of gestation
- Dose / conc.:
- 1 908 mg/kg bw/day (actual dose received)
- Remarks:
- 2 mL/kg; calculated based on a density value of 0.954 g/mL
- Dose / conc.:
- 9 540 mg/kg bw/day (actual dose received)
- Remarks:
- 10 mL/kg; calculated based on a density value of 0.954 g/mL
- No. of animals per sex per dose:
- 20 parental females
- Control animals:
- other: physiological saline or soybean oil
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: on Days 0, 7 and 18 of gestation - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: Yes: all per litter
- Head examinations: No - Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No differences were observed between test substance administration group, control group and soybean oil administration group. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 540 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity: no adverse effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
External abnormalities: cleft palate was observed in 1 foetus of control, 1 foetus of the 2 mL/kg bw/day dose group and 3 foetuses of the 10 mL/kg bw/day dose group. No cleft palate was found in foetuses receiving soybean oil. Club foot was observed in 1 foetus of control, 4 foetuses of the soybean oil control group, 3 foetuses of the 2 mL/kg bw/day dose group and 4 foetuses of the 10 mL/kg bw/day dose group.
Skeletal abnormalities: Two foetuses showed assimilation of the ribs in the 2 mL/kg bw/day dose group. One foetus showed assimilation of the cervical vertebra in the 10 mL/kg bw/day dose group. However, these effects did not follow a clear dose-dependency. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 540 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity: no adverse effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No soft tissue and head examinations were performed in foetuses.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A teratogenicity study in rabbits was conducted in 1970, prior to the adoption of any OECD guideline.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kansai Institute for Experimental Animals, Japan
- Weight at study initiation: 2.5-3.8 kg (range)
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-60 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No detailed information is available.
- Duration of treatment / exposure:
- Day 7-16 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Day 29 of gestation
- Dose / conc.:
- 2 862 mg/kg bw/day (actual dose received)
- Remarks:
- 3 mL/kg bw; calculated based on a density value of 0.954 g/mL
- No. of animals per sex per dose:
- 8 parental females
- Control animals:
- other: physiological saline and soybean oil
- Details on study design:
- - Dose selection rationale: in a preliminary study, mortality was observed after administration of the test substance at 5 and 10 mL/kg bw/day. Therefore, a dose of 3 mL/kg bw/day was selected for treatment in this study.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 7 and 18 of gestation - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: Yes: all per litter
- Head examinations: No - Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No major differences in mean body gain during gestation period was seen between control rabbits and rabbits treated with soybean oil or glycerol trioctanoate.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects: No differences were observed between test substance administration group, control group and soybean oil administration group.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 862 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No abnormalities in treated animals. Abnormalities were only seen in the soybean and control group.
External abnormalities: hydrocephalus (1 foetus) and absence of the head (1 foetus) was observed in the soybean oil group.
Skeletal abnormalities: Division of the skull was observed in 4 foetuses of the control group and 1 foetus of the soybean oil group. One foetus of the soybean oil group showed assimilation of the ribs. - Visceral malformations:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 862 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity; no adverse effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- No indication for develomental toxicity.
Referenceopen allclose all
Table 1. Effects on foetuses of parental females treated with the test substance (2 and 10 mL/kg) and soybean oil
Groups |
No of mothers |
No. of fetuses |
Live fetuses |
Dead |
|||||
No. |
Mean body weight (g) |
No. of resorbed fetuses |
No. of dead fetuses |
Total (%) |
|||||
M. |
F. |
M.+F. |
|||||||
Control (saline) |
20 |
232 (11.6 ± 0.39) |
116 |
104 |
220 |
1.28 ± 0.023 |
11 |
1 |
12 (5.2) |
Soybean oil |
20 |
223 (11.1 ± 0.46) |
101 |
114 |
215 |
1.26 ± 0.021 |
6 |
2 |
8 (3.6) |
2 mL/kg |
20 |
231 (11.5 ± 0.29) |
113 |
107 |
220 |
1.29 ± 0.023 |
9 |
2 |
11 (4.8) |
10 mL/kg |
20 |
232 (11.6 ± 0.40) |
107 |
112 |
219 |
1.26 ± 0.030 |
12 |
1 |
13 (5.6) |
M.: male, F.: female
(Mean ± standard error)
Table 2. Malformations in foetuses of parental females treated with the test substance (2 and 10 mL/kg) and soybean oil
Group |
Malformed |
||
No. (%) |
Number of fetuses: Type |
||
Ex |
Sk |
||
Control (saline) |
3 (1.4) |
0 |
1: Curled tail 1: Cleft palate 1: Club foot |
Soybean oil |
4 (1.9) |
0 |
4: Club foot |
2 mL/kg |
4 (1.8) |
2 (0.9) |
1: Cleft palate 3: Club foot 2: Assimilation of the ribs |
10 mL/kg |
7 (3.2) |
1 (0.5) |
3: Cleft palate 4: Club foot 1: Assimilation of the cervical vertebra |
Ex: external malformation
Sk: skeletal malformation
Table 1. Effects on foetuses of parental females treated tricaprylin (3 mL/kg bw), soybean oil and controls
Groups |
No of mothers |
No. of fetuses (mean per litter) |
Live fetuses |
Dead |
|||||
No. |
Mean body weight (g) |
No. of resorbed fetuses |
No. of dead fetuses |
Total (%) |
|||||
M. |
F. |
M.+F. |
|||||||
Control |
8 |
69 (8.6 ± 1.36) |
35 |
23 |
58 |
36.2 ± 2.55 |
7 |
4 |
11 (15.9) |
Soybean oil |
8 |
65 (8.1 ± 1.26) |
34 |
28 |
62 |
38.6 ± 2.21 |
2 |
1 |
3 (4.8) |
Tricaprylin 3 mL/kg |
8 |
72 (9.0 ± 0.60) |
28 |
33 |
61 |
34.9 ± 1.47 |
4 |
7 |
11 (15.3) |
M.: male, F.: female
Mean ± standard error
Table 2. Malformations in foetuses of females treated with the test substance (3 mL/kg) or soybean oil
Group |
Malformed |
||
No. (%) |
Type |
||
Ex |
Sk |
||
Control |
0 |
4 (6.9) |
4: Division of the skull |
Soybean oil |
2 (3.2) |
2 (3.2) |
1: Hydrocephalus 1: Absence of the head 1: Assimilation of the ribs 1: Division of the skull |
3 mL/kg |
0 |
0 |
|
Ex: external malformation
Sk: skeletal malformation
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 862 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- The available information comprised well documented studies with the target substance, meeting generally accepted scientific principles, acceptable for assessment (Klimisch score 2).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
CAS 538-23-8
An non-guideline teratogenicity study was performed in rabbits (WoE, 1970, rabbit). Eight female animals were administered glycerol trioctanoate (CAS 538-23-8) on days 7-16 of gestation at 3 mL/kg bw once daily by oral gavage, equivalent to 2862 mg/kg bw/day. No treatment-related effects were seen on the incidence of clinical signs, body weight, number of implantations, early resorptions, number of total litter losses by resorption, number of live foetuses, and external and skeletal examination of foetuses.
A non-guideline teratogenicity study was performed in mice (WoE, 1970, mouse). Twenty female animals per dose were administered glycerol trioctanoate (CAS 538-23-8) on days 7-12 of gestation at 2 and 10 mL/kg bw once daily by oral gavage, equivalent to 1908 and 9540 mg/kg bw/day. No treatment-related effects were seen on the incidence of clinical signs, body weight, number of implantations, early resorptions, number of total litter losses by resorption, number of live foetuses, and external and skeletal examination of foetuses.
Overall conclusion for developmental toxicity/teratogenicity
No adverse effects on developmental toxicity and no teratogenic effect were seen in the available studies with glycerol trioctanoate (CAS 538-23-8) performed in rabbits and mice. The studies were conducted in 1970, prior to the adoption of OECD testing guidelines, but were acceptable for assessment. The NOAEL values for developmental toxicity/teratogenicity were found to be greater than 1000 mg/kg bw/day. Based on the available data glycerol trioctanoate (CAS 538-23-8) is considered to be not toxic to uterine development.
Mode of Action Analysis / Human Relevance Framework
Not applicable
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to glycerol trioctanoate (CAS 538-23-8), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Based on the available data from the target and source substances on toxicity to reproduction and development, glycerol trioctanoate (CAS 538-23-8) does not meet the classification criteria according to Regulation (EC) 1272/2008, and is therefore conclusive but not sufficient for classification.
Additional information
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.