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EC number: 202-468-3 | CAS number: 95-96-5
- 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
Description of key information
There are no studies available for the assessment of the oral, inhalation and dermal acute toxicity for the target substance dilactide. Therefore, data available from the suitable read-across substance L(+)-lactic acid, D-lactide and L-lactide was used to assess the acute toxicity via the standard routes of administration (oral, inhalation, dermal).
A sample of D-lactide (purity >99.5%) was
examined for acute oral toxicity in an experiment conducted according to
OECD guideline 423 with female rats. A dose level of 2000 mg/kg bw was
examined. No mortality or distinct clinical signs were observed after
treatment of 6 females with 2000 mg/kg bw.
In an acute dermal toxicity study, a group of young adult Wistar rats (5
males and 5 females) were dermally exposed to D-lactide (purity 99%) in
polyethylene glycol 400 for 24 hours to approximately 10% of body
surface area at 2000 mg/kg bw. Animals were observed for 14 days. No
mortality occurred. There were no treatment related clinical signs,
necropsy findings or changes in body weight. In addition, L-lactide was
examined in an acute oral toxicity test and in an acute dermal toxicity
study. In both GLP guideline studies no effects were observed after
treatment with 2000 mg/kg bw . D- and L-lactide are suitable read across
partners as Dilactide is a mixture of D- and L-lactide isomers.
L(+)-lactic acid is used additionally as a read-across partner for dilactide
in an acute inhalation toxicity study (OECD TG 403) in rats, in which a
LC50 of > 7.94 mg/L was determined.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Body weight:
- other body weight observations
- Remarks:
- No adverse effects on body weight
- Gross pathology:
- Examination at autopsy of the males and females did not reveal treatment-related gross alterations.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Since no mortality occurred during the 14-day observation period, the LD50 of L-lactide exceeds 2000 mg/kg bw in both male and female rats. Therefore, L-lactide is considered not harmful after oral ingestion.
- Executive summary:
In an acute oral toxicity study conducted according to OECD guideline 423, a group of male and female Wistar outbred rats; Crl:(WI) WU BRA (n = 3/sex) were given a single oral dose of L-lactide (purity > 99.5%) at a dose level of 2000 mg/kg body weight.
No mortality or distinct clinical signs were observed after treatment. Macroscopic examination of the animals at the end of the observation period did not reveal any treatment-related gross changes. Since no mortality occurred during the 14-day observation period, the acute oral LD50 of L-lactide is considered to exceed 2000 mg/kg body weight, in both male and female rats. L-lactide is considered to be not harmful after oral ingestion.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture was noted for all animals on day 1. In addition, lethargy and piloerection were noted among the majority of animals on day 1.
- Body weight:
- other body weight observations
- Remarks:
- No adverse effects observed
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- N.A.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Since no mortality occurred during the 14-day observation period, the LD50 of D-lactide exceeds 2000 mg/kg bw in female rats. Therefore, D-lactide is considered as not harmful upon ingestion.
- Executive summary:
In an acute oral toxicity study conducted according to OECD guideline 423, group of male and female Wistar rats (n= 3/sex) were given a single oral dose of D-lactide (purity >99%) at a dose level of 2000 mg/kg body weight.
No mortality or distinct clinical signs, except hunched posture, piloerection and lethargy on day 1, were observed after treatment of 6 females with the 2000 mg/kg bw dose level. Macroscopic examination of the animals at the end of the observation period did not reveal any treatment-related gross changes. Since no mortality occurred during the 14-day observation period, the oral LD50 of D-lactide is considered to exceed 2000 mg/kg bw in female rats. D-lactide is considered as not harmful upon ingestion.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Guideline studies
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration of exposure:
- h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 7.94 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- 1 female died.
- Clinical signs:
- other: Please refer to box "Any other information on results incl. tables".
- Body weight:
- At the beginning of the study, mean body weicihts for individual groups were within 20% of the overall mean for each sex. All groups of male rats gained weight within the first week after exposure in comparison to pre-exposure weights (3% for sham-exposed, 2< for L(+)-lactic acid,respectively). Female rats in the sham group gained weight during the first week after exposure (less than 1%). Female rats in the treated group lost weight during the first week after exposure (7%). After 14 days, all surviving animals had gained weight in comparison to pre-exposure weights (14% for males, 7% for females). No significant differences were observed in body weight between treated and control groups.
- Gross pathology:
- All surviving animals were necropsied at the termination of the study. The animal that died during the study was necropsied immediately. No gross lesions were observed at necropsy.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Based on these results, the LC50 of L(+)-lactic acid is greater than 7.94 mg/L.
- Executive summary:
In an acute inhalation toxicity study according to OECD 403, groups of young adult F344 rats (5/sex/dose) were exposed by inhalation route to L(+)-lactic acid in a concentration of approximately 7.94 mg/L for 4 hours.
Rapid breathing and eye tearing were observed during exposure. At one and three hours after exposure, all animnals (including the sham controls) had a hunched posture, ruffled and ungroomed fur, brown stained fur and red-stained fur surrounding the eyes (tearing). After 24 hours, female treated rats had ruffled and stained coats. All other animals appeared normal at 24 hours and for the remainder of the 14 day observation period. Several treated female rats continued to have ruffled fur up to 4 days after exposure. One female rat from the treated group died on day 9. All other animals survived until the end of the study. At gross pathology no adverse lesions were observed.
Based on these results, the LC50 of L(+)-lactic acid is greater than 7.94 mg/L.
This acute inhalation study is classified as acceptable. It does satisfy the guideline requirement for an acute inhaltion study (OECD TG 403) in rats.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reference
Clinical signs:
Rapid breathing and eye tearing were observed during exposure. At one and three hours after exposure, all animals (including the sham controls) had a hunched posture, ruffled and ungroomed fur, brown stained fur and red-stained fur surrounding the eyes (tearing). By 24 hours, female treated rats had ruffled and stained coats. All other animals appeared normal at 24 hours and for the remainder of the 14 day observation period. Several treated female rats continued to have ruffled fur up to 4 days after exposure.
Mass Median Diameter:
The Mass Median Diameters ranged from 2.03 to 2.14 microns and averaged 2.09.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 7.94 mg/L air
- Physical form:
- inhalation: aerosol
- Quality of whole database:
- Guideline study
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Chromodacryorrhoea (snout) was noted for one male on Day 1. No further clinical signs were observed
- Body weight:
- other body weight observations
- Remarks:
- No adverse effects observed
- Gross pathology:
- Reddish discolouration of the uterine adipose tissue in the abdominal cavity was observed for one female.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The dermal LD50 value of L-lactide in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study conducted according to OECD guideline 402, a group of young adult Wistar rats (5 males and 5 females) was dermally exposed to L-lactide (purity 99%) in polyethylene glycol 400 for 24 hours to approximately 10% of body surface area at 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred. There were no treatment related clinical signs, necropsy findings or changes in body weight. The dermal LD50 value of L-lactide in Wistar rats was established to exceed 2000 mg/kg body weight.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Chromodacryorrhoea (left eye) was noted for one male on day 2. One male showed scabs on day 6 and scales on day 7 in the treated skin area.
- Body weight:
- other body weight observations
- Remarks:
- No adverse effects were observed
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The dermal LD50 value of D-lactide in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study conducted according to OECD guideline 402, a group of young adult Wistar rats (5 males and 5 females) was dermally exposed to D-lactide (purity 99%) in polyethylene glycol 400 for 24 hours to approximately 10% of body surface area at 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred. There were no treatment related necropsy findings or changes in body weight. Clinical signs as e.g. chromodacryorrhoea (left eye) was noted in one male on day 2 and one male shoed scabs on day 6 and scales on day 7 in treated skin area.
The dermal LD50 value of D-lactide in Wistar rats was established to exceed 2000 mg/kg body weight.
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Guideline studies
Additional information
There are no studies available for the assessment of the oral, inhalation and dermal acute toxicity for the target substance dilactide. Therefore, data available from the suitable read-across substance L(+)-lactic acid, D-lactide and L-lactide was used to assess the acute toxicity via the standard routes of administration (oral, inhalation, dermal).
After oral application of rats on the one hand with L-lactide and on the other hand with D-lactidein studies conducted in accordance with OECD 423 an acute oral LD50 of L-lactide and D-lactide of > 2000 mg/kg bw was determined. After dermal application in studies conducted in accordance to OECD guideline 402, the LD50 of L-lactide and D-lactide was determined with > 2000 mg/kg bw. L- and D-lactide are suitable read across partners as dilactide is a mixture of D- and L-lactide isomers.
L(+)-lactic acid is an acceptable
read-across partner as lactide is rapidly converted by hydrolysis into
lactic acid under aqueous conditions. In an acute inhalation toxicity
study in rats with lactic acid conducted in accordance with OECD
guideline 403 a LC50 of > 7.94 mg/L air was determined.
Justification for classification or non-classification
Based on the available data, the target substance dilactide does not warrant classification for acute toxicity in accordance with CLP Regulation 1272/2008.
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