[2-(2-methoxymethylethoxy)methylethoxy]propanol

Endpoint summary

Description of key information

A non-GLP study with dermal application of tripropylene glycol methyl ether over 90-days to rabbits and a GLP-study according to OECD guideline 412 (2-week inhalation exposure in rats and mice) are available for tripropylene glycol methyl ether. Supporting data from category member DPM (refer to category document attached to section 13 of the IUCLID).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with GLP as well as comparable to guidelines and sufficient data is available for the interpretation study results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)

GLP compliance:

yes

Limit test:

no

Species:

other: Rat and Mice

Strain:

other: Fischer - 344 and Mice - B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source:
Rats - Charles River Breeding Laboratories. Inc, Kingston
Mice - Mice - Charles River Breeding Laboratories. Inc, Portage MI
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Rats:
Rats: Male - 177 to 182 gms and Female - 127 to 129 gms
Mice: Male - 24 to 25 gms and Female - 21 to 22 gms
- Housing: Rats were housed singly in stainless steel cages with wire bottoms
- Diet ( ad libitum): Purina Certified Rodent Chow # 5002
- Water ( ad libitum): Municipal tap water except during exposure.
- Acclimation period: 7 days each for rat and mice


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2°C
- Humidity (%): 50 %
- Air changes (per hr):
- Photoperiod: (12 hrs dark / 12 hrs light)


IN-LIFE DATES: Not specified in the report

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 1m³ stainless steel and glass chamber used.
- Method of holding animals in test chamber: Whole body
- Method of conditioning air:
- System of generating particulates/aerosols: The aerosol test atmospheres were generated using a spraying nozzle.
- Temperature, humidity, pressure in air chamber: Temperature 70°F and Humidity 50%
- Air flow rate: 200 lit/minute
- Method of particle size determination: Particle size distribution of the TPGME aerosol was measured once per day in each exposure chamber using an APS Aerodynamic partcle sizer and diluter.


TEST ATMOSPHERE
- Brief description of analytical method used: The aerosol concentration was measured gravimetrically approximately 4 to 5 times per day in each chamber.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

See the Attachment - 1

Duration of treatment / exposure:

2 weeks (total of 9 exposures)

Frequency of treatment:

6 hrs/day for a total of 9 days

Remarks:

Doses / Concentrations:
0.15 mg/l
Basis:
analytical conc.

Remarks:

Doses / Concentrations:
0.36 mg/l
Basis:
analytical conc.

Remarks:

Doses / Concentrations:
1.01 mg/l
Basis:
analytical conc.

No. of animals per sex per dose:

5/sex/dose/species

Control animals:

yes

Details on study design:

Post-exposure period: none

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All animals were observed after each exposure period along with daily observations.
BODY WEIGHT: Yes
- Time schedule for examinations: All animals were weighed prior to 1st, 3rd, 5th and 9th days of exposure
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Immediately prior to sacrifice
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: Rats - 20 male and 20 Female Mice- 20 Male and 18 Female
- Parameters checked: RBC, HGB, PCV, MCV, MCH, MCHC, Plat, WBC, LYM, MON, EOS


CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:Immediately prior to sacrifice
- Animals fasted: Yes
- How many animals:Rats - 20 male and 20 Female Mice- 20 Male and 18 Female
- Parameters checked: BUN, GPT, AP, GOT, GLUC, TP, ALB, and GLOB

URINALYSIS: Yes (only in rats)
- Time schedule for collection of urine: Urine samples were collected from rats prior to the 9th exposure
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked: Bilirubin, Glucose, Ketones, Blood, pH, Protein, Urobilinigen, Specific gravity

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
All surviving animals were sacrificed the day following the last exposure. Rats were fasted overnight prior to the scheduled sacrifice, mice were not fasted prior to sacrifice. All animals were weighed, anesthetized with methoxyflurane, and trachea was clamped prior to decapitation. All animals were examined for gross pathological alterations. The necropsy included in situ examination of the eyes by a glass slide technique with fluorescent illumination.
HISTOPATHOLOGY: Yes
A complete set of tissues was collected from each animal and preserved in neutral phosphate buffered formalin. The lungs were infused with buffered formalin to their approximate normal inspiratory volume and the nasal cavity was flushed with formalin via pharyngeal duct to insure rapid fixation of the tissue.Histopathologic examinations were performed on complete sets of tissues from all rats and mice in control and high exposure groups. Only target organs identified in the high exposure were examined histopathologically for animals in the middle and low exposure groups. Tissues that were examined histopathologically were processed by conventional techniques, stained with hematoxylin and eosin and evaluated by light microscopy.

Other examinations:

Organ weights: liver, kidneys, thymus, testes, heart and brain, from all surviving animals.

Statistics:

Descriptive statistics are reported for differential counts and RBC indices. Body weights, absolute and relative organ weights, clinical chemistry data, appropriate hematology data and urinary specific gravity were evaluated by Bartlett's test, for equality of variances. Based on the outcome of Bartlett's test, a parametric or non-parametric analysis of variance (ANOVA) was performed, followed respectively by Dennett’s test with a Bonferroni correction for multiple comparisons. Statistical outliers were identified by a sequential test but not excluded from statistical analyses.

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY: One female mouse in the control group and one in the 0.15 mg/l group died as a result of accidental traumatic injuries. All other rats and mice survived until the scheduled necropsy with no apparent indication of an adverse response to the test material except that slight nasal exudate was noted for rats in the high exposure groups following last exposure. The fur of the animals in high exposure group was slightly wet following each day of exposure as a result of the high concentration of liquid aerosol in that chamber.

BODY WEIGHT AND WEIGHT GAIN: The mean body weights of male and female rats and mice were not adversely affected by exposure to the test material. There were no statistically significant differences in the mean body weights of control and exposure groups of animals at any time the course of the study.

HAEMATOLOGY: The hematology analyses for the male and female rats and mice were unremarkable, revealing no differences between control and exposure group of animals.


CLINICAL CHEMISTRY: The clinical chemistry analyses for rats and mice indicated no changes that were considered to be diagnostic of an adverse effect on any organ or tissue.


URINALYSIS: The mean urinary specific gravity values for female rats in the 0.15 mg/l and 1.01 mg/l groups were statistically significantly lower than for the controls however; the degree of the change was not proportional to exposure concentration. In view of the absence of a clear dose -response relationship, the observed changes in urinary specific gravity in female rats were not considered to be of toxicologic significance. There were no clinical chemistry changes in these animals which were diagnostic of adverse renal effects and histopathologic changes in the kidneys.


ORGAN WEIGHTS: At necropsy the mean absolute and relative liver weights of male and female rats in the high exposure group, as well as the mean relative liver weight of male rats in the 0.36 mg/l group, were significantly higher than for the controls. Significant increases in the mean liver weights were also found in mice. The liver weights of male mice were increased an all three exposure groups in an apparent exposure concentration related manner, while the liver weights of female mice were affected only at the high 1.01 mg/l exposure concentration. The weights of brain, heart, kidneys, thymus, testes in rats and mice were not affected by exposure to the TPGME aerosol.


GROSS PATHOLOGY: At necropsy the livers of some treated animals appeared to be larger than for controls otherwise, there were no treatment related gross pathologic observations in either rats or mice.


HISTOPATHOLOGY: NON-NEOPLASTIC: Histopathologic examinations revealed no adverse exposure related changes in any organ or tissue in either rats or mice. Some of the male mice (3 of 5) in the 1.01 mg/l group had altered tinctorial properties in peripheral regions of hepatic lobules; this observation was considered to be an adaptive response rather than a degenerative phenomenon. There were no microscopic exposure related changes in the livers of rats and mice and no microscopic observations in the kidneys of female rats associated with the changes in the specific gravity of urine. The gross and histopathologic observations for two female mice that were accidentally killed during the course of the study revealed no changes related to exposure to TPGME.

Dose descriptor:

NOAEC

Effect level:

1 010 mg/m³ air

Sex:

male/female

Basis for effect level:

other: based on adaptive effects on the liver

Critical effects observed:

not specified

Conclusions:

Based on the results of this study the NOAEC (based on adaptive effect on the liver) is 1.01 mg/l for both species.

Executive summary:

Fischer – 344 (5/sex/exposure concentration) and B6C3F1 mice (5/sex/exposure concentration) were exposed to 0, 0.15, 0.36, and 1.01 mg/l or 0,150, 360, 1010 mg/m3) of tripropylene glycol monomethyl ether (colorless liquid aerosol TPGME) for 6 hrs/day, for a total of 9 days.

Rats were received from Charles River Breeding Laboratories Inc. Kingston and mice were received from Charles River Breeding Laboratories Portage, MI,. Rats and mice were kept for an acclimatization period of 7 days. Rats were housed singly in stainless steel cages with wire bottoms. A standard laboratory diet (Purina Certified laboratory Chow, Ralson Purina Co., . MO) was supplied to rats and mice. Water also provided ad libitum to rats and mice except during exposure. Housing conditions were maintained at temperature of 22.4 °C with relative humidity of 50%.

Monitored for effects included general observations, body weights, clinical chemistry, hematology, urinalysis (Rats only), necropsy, organ weights and histopathology.

The mean body weights of rats and mice were not adversely affected by exposure to the test material. There were no statistically significant differences in the mean body weights of control and exposure groups of animals at any time the course of the study.All animals were survived until the scheduled necropsy with no apparent indication of an adverse response to the test material except that slight nasal exudate was noted for rats in the high exposure groups following last exposure. One female mouse in the control group and one in the 0.15 mg/l group dies as a result of accidental traumatic injuries. The fur of the animals in high exposure group was slightly wet following each day of exposure as a result of the high concentration of liquid aerosol in that chamber. The haematology analyses for the male and female rats and mice were unremarkable, revealing no differences between control and exposure group of animals. The clinical chemistry analyses for rats and mice indicated no changes that were considered to be diagnostic of an adverse effect on any organ or tissue.

The mean urinary specific gravity values for female rats in the 0.15 mg/l and 1.01 mg/l groups were statistically significantly lower than for the controls however; the degree of the change was not proportional to exposure concentration. In view of the absence of a clear dose -response relationship, the observed changes in urinary specific gravity in female rats were not considered to be of toxicologic significance. There were no clinical chemistry changes in these animals which were diagnostic of adverse renal effects and histopathologic changes in the kidneys.

At necropsy the mean absolute and relative liver weights of male and female rats in the high exposure group, as well as the mean relative liver weight of male rats in the 0.36 mg/l group, were significantly higher than for the controls. Significant increases in the mean liver weights were also found in mice. The liver weights of male mice were increased an all three exposure groups in an apparent exposure concentration related manner, while the liver weights of female mice were affected only at the high 1.01 mg/l exposure concentration. The weights of brain, heart, kidneys, thymus, testes in rats and mice were not affected by exposure to the TPGME aerosol.

At necropsy the livers of some treated animals appeared to be larger than for controls otherwise, there were no treatment related gross pathologic observations in either rats or mice. Histopathologic examinations revealed no adverse exposure related changes in any organ or tissue in either rats or mice. Some of the male mice (3 of 5) in the 1.01 mg/l group had altered tinctorial properties in peripheral regions of hepatic lobules; this observation was considered to be an adaptive response rather than a degenerative phenomenon. There were no microscopic exposure related changes in the livers of rats and mice and no microscopic observations in the kidneys of female rats associated with the changes in the specific gravity of urine. The gross and histopathologic observations for two female mice that were accidentally killed during the course of the study revealed no changes related to exposure to TPGME.

Based on the results of this study the NOAEC (based on adaptive effect on the liver) is 1.01 mg/l.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEC

1 010 mg/m³

Study duration:

subacute

Species:

rat

Quality of whole database:

good

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1952

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and guidelines but sufficient data is available for the interpretation of study results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)

GLP compliance:

no

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

male

Type of coverage:

occlusive

Vehicle:

other: Distilled water

Details on exposure:

Route of Administration: dermal
TEST SITE
- Area of exposure: Shaved abdomen of rabbit
- Type of wrap if used: Impervious saran wap
- Time intervals for shavings or clipplings:

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

Not specified in the report

Duration of treatment / exposure:

90 days

Frequency of treatment:

5 times a week

Remarks:

Doses / Concentrations:
1.0 ml/kg
Basis:
nominal per unit body weight

Remarks:

Doses / Concentrations:
3.0 ml/kg
Basis:
nominal per unit body weight

Remarks:

Doses / Concentrations:
5.0 ml/kg
Basis:
nominal per unit body weight

Remarks:

Doses / Concentrations:
10 ml/kg
Basis:
nominal per unit body weight

No. of animals per sex per dose:

Control- 5 animals
1 ml/kg-6 animals
3 ml/kg-7 animals
5 ml/kg-8 animals
10 ml/kg-8 animals

Control animals:

yes

Details on study design:

Post-exposure period: none

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily


BODY WEIGHT: Yes
- Time schedule for examinations: Weekly


HAEMATOLOGY: Yes
- Time schedule for collection of blood: Prior to study begun, 30th day, 90th day

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes At necropsy, samples from liver, kidneys, spleen, adrenals, heart, lungs, and G.I. tract collected for processing into slides for histological evaluation.

Other examinations:

organ weights were also monitored.

Statistics:

Not specified.

Clinical signs:

effects observed, treatment-related

Dermal irritation:

not examined

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY: The highest dose, 10 ml/kg-d, produced narcosis and death in 7 of 8 of the subjects. All but one non-survivor died within 3 weeks of initiation of treatment. The remaining non-survivor died during the 10th week of exposure. Other observations in the high dose group included weight loss .

BODY WEIGHT AND WEIGHT GAIN: At 3.0 ml/kg and 5.0 ml/kg-d dose levels body weight loss was evident on days 84 and 90 but not at earlier exposure times.

HAEMATOLOGY: Hematology was normal at all dose levels

ORGAN WEIGHTS: At 3 ml/kg and 5.0 ml/kg-d dose levels kidney weights were increased.

GROSS PATHOLOGY: Gross examination of the skins of the rabbits at the site of TPM application indicated occasional erythema "scalding" but did not reveal significant severity or incidence differences from water treated controls. Autopsy of the high dose group showed that organs appeared normal when examined grossly.

HISTOPATHOLOGY: NON-NEOPLASTIC: Histopathology was largely normal in all organs in the high dose group with the exception that kidneys occasionally showed granular degeneration and hydropic changes. Oddly, at 1.0 ml/kg and 3.0ml/kg, but not at 5.0 ml/kg-d, tubular necrosis was observed in some rabbits.

Dose descriptor:

NOAEL

Effect level:

965 other: mg/kg

Sex:

male

Basis for effect level:

other: Overall effects

Dose descriptor:

LOAEL

Effect level:

2 895 other: mg/kg

Sex:

male

Basis for effect level:

other: Overall effects

Critical effects observed:

not specified

Conclusions:

Based on the results of this study NOAEL is 1.0 ml/kg (965 mg/kg) and the LOAEL is 3.0 ml/kg (2895 mg/kg) based on increased kidney weights and decreased body weights later in the study.

Executive summary:

Groups of 5 to 8 adult rabbits per dose level received topical applications of tripropylene glycol methyl ether at doses of 0, 1.0 ml/kg, 3 ml/kg, 5 ml/kg, 10 ml/kg five days per week over a period of 3 months (for a total of 65 applications).Tripropylene glycol methyl ether was applied to a gauze pad (7.5 ×7.5 cm sq) at the appropriate dose level. This pad was applied to clipped or shaved abdomen of the rabbit, covered with impervious saran wrap covered with heavy cloth and secured to the rabbit with adhesive tape. This application procedure was repeated 5 times per week.

Monitored for effects included general observations, body weights, clinical hematology, necropsy, organ weights and histopathology. At 3.0 ml/kg and 5.0 ml/kg-d dose levels body weight loss was evident on days 84 and 90 but not at earlier exposure times.

The highest dose level 10 ml/kg-d, produced narcosis and death in 7 of 8 of the subjects. All but one non-survivor died within 3 weeks of initiation of treatment. The remaining non-survivor died during the 10th week of exposure. Other observations in the high dose group included weight loss.

The hematology analyses for the rabbits were unremarkable, revealing no differences between control and exposure group of animals At 3 ml/kg and 5.0 ml/kg-d dose levels kidney weights were increased.

Gross examination of the skins of the rabbits at the site of TPM application indicated occasional erythema "scalding" but did not reveal significant severity or incidence differences from water treated controls. Autopsy of the high dose group showed that organs appeared normal when examined grossly.

Histopathology was largely normal in all organs in the high dose group with the exception that kidneys occasionally showed granular degeneration and hydropic changes. Oddly, at 1.0 ml/kg and 3.0ml/kg, but not at 5.0 ml/kg-d, tubular necrosis was observed in some rabbits.

Based on the results of this study NOAEL is 1.0 ml/kg (965 mg/kg) and the LOAEL is 3.0 ml/kg (2895 mg/kg) based on increased kidney weights and decreased body weights later in the study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

965 mg/kg bw/day

Study duration:

subchronic

Species:

rabbit

Quality of whole database:

Good (Klimisch 2)

Additional information

Dermal route: Groups of 5 to 8 adult rabbits per dose level received topical applications of tripropylene glycol methyl ether at doses of 0, 1.0 ml/kg, 3 ml/kg, 5 ml/kg, 10 ml/kg five days per week over a period of 3 months (for a total of 65 applications). The highest dose level 10 ml/kg-d, produced narcosis and death in 7 of 8 of the subjects. The hematology analyses for the rabbits were unremarkable, revealing no differences between control and exposure group of animals At 3 ml/kg and 5.0 ml/kg-d dose levels kidney weights were increased. Gross examination of the skins of the rabbits at the site of TPGME application indicated occasional erythema "scalding" but did not reveal significant severity or incidence differences from water treated controls. Autopsy of the high dose group showed that organs appeared normal when examined grossly. Histopathology was largely normal in all organs in the high dose group with the exception that kidneys occasionally showed granular degeneration and hydropic changes. Oddly, at 1.0 ml/kg and 3.0ml/kg, but not at 5.0 ml/kg-d, tubular necrosis was observed in some rabbits. Based on the results of this study NOAEL is 1.0 ml/kg (965 mg/kg) and the LOAEL is 3.0 ml/kg (2895 mg/kg) based on increased kidney weights and decreased body weights later in the study.

Inhalation route: In a 2-week aerosol inhalation study rats and mice were exposed to 0, 150, 360, 1010 mg/m3 of tripropylene glycol monomethyl ether (TPGME). Monitoring for effects included general observations, body weights, clinical chemistry, hematology, urinalysis (rats only), necropsy, organ weights and histopathology. At necropsy the mean absolute and relative liver weights of rats and mice in the high exposure groups were significantly higher than for the controls. At necropsy the livers of some treated animals appeared to be larger than for controls otherwise, there were no treatment related gross pathologic observations in either rats or mice. Histopathologic examinations revealed no adverse exposure related changes in any organ or tissue in either rats or mice. Some of the male mice (3 of 5) in the 1.01 mg/l group had altered tinctorial properties in peripheral regions of hepatic lobules; this observation was considered to be an adaptive response rather than a degenerative phenomenon. There were no microscopic exposure related changes in the livers of rats and mice and no microscopic observations in the kidneys of female rats associated with the changes in the specific gravity of urine. The liver weight increase was only observed in the high dose groups. There were no histopathological changes accompanying this effect. There were no changes in clinical chemistry (ALP, ASP) indicating any liver damage. The same effects were observed with other structurally related molecules, e.g. propylene glycol methyl ether has been shown to cause liver weight increases via a phenobarbital-like enzyme induction mode of action and it is highly likely that tripropylene glycol methyl ether liver weight increases occur via the same mode of action. As this is an adaptive effect typical for many glycol ethers, it is not considered as adverse. Based on the results of this study the NOAEC (based on adaptive changes in the liver) in rats and mice is 1.01 mg/l.

In addition to the short term study using TPGME, there are 90 -day inhalation studies in rats and rabbits for the category member DPM that can be used to characterise the repeated dose inhalation toxicity of TPGME. In the available studies for DPM, no significant adverse effects were observed in rats or rabbits following inhalation exposures of up to 200ppm 6h/day, 5d/week for 90 days. As such the NOAEL for DPM in these studies is 200ppm. This is equivalent to 1232 mg/m3. Considering the consistency of these findings with those observed with the aerosol study using TPGME, the NOEC from the aerosol study with TPGME of 1010 mg/m3 will be taken as the starting point for inhalation DNELS, but the assessment factor for study duration will be reduced (refer to DNEL derivation section).

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
reliable study on the test material, supported by data from a category member

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
This is the only study available

Repeated dose toxicity: inhalation - systemic effects (target organ) digestive: liver

Repeated dose toxicity: dermal - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification

The no observed adverse effect levels for tripropylene glycol methyl ether exceed the values triggering classification via all routes of exposure. Therefore no classification for prolonged exposure is required.