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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 Jul - 10 Oct 1986
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no data on test substance purity; only 2 dose groups, open application, limited parameters examined)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
(no data on test substance purity, only 2 dose groups, open application, limited parameters examined)
GLP compliance:
Limit test:

Test material

Constituent 1
Reference substance name:
Cas Number:
Details on test material:
- Name of test material (as cited in study report): [trade name]- Substance type: polyol ester- Physical state/appearance: light yellow liquid- Analytical purity: no data- Relative density: 1.00

Test animals

Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Charles River, Lakeview, NJ, USA- Age at study initiation: approx. 7 weeks- Housing: individually in hanging, stainless steel cages with wire bottoms and fronts- Diet: Purina Certified Lab Chow ' 5002 in pellet form; ad libitum- Water: tap water; ad libitum- Acclimation period: at least 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-22 - Humidity (%): 40-60- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on exposure:
TEST SITE- Area of exposure: no data- Type of wrap if used: no wrap used, open- Time intervals for shavings or clipplings: 24 h before the first treatment; at least weekly afterwards- Application site: back (shaved)REMOVAL OF TEST SUBSTANCE- Washing (if done): no washing; wiping off with a gauze pads every saturday (applications on working days)TEST MATERIAL- Amount(s) applied (volume or weight with unit): no data - Concentration (if solution): undiluted- Constant volume or concentration used: noUSE OF RESTRAINERS FOR PREVENTING INGESTION: yes (collars), removal during the weekend
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
5 days per week (65 exposures), 24 hours/day, removal of substance on saturdays (once a week)
Doses / concentrations
Doses / Concentrations:800 and 2000 mg/kg bw/dayBasis:nominal per unit body weight
No. of animals per sex per dose:
10(5 additional animals of the control and the high dose group were included for dermal bioavailability experiments only.)
Control animals:
yes, concurrent no treatment
Details on study design:
The test substance was dispensed by volume from a syringe and left uncovered on the shaved skin. The rats were fitted with cardboard Elizabethan collars to minimze ingestion of the test material. The controls were treated in the same manner except that no material was applied to their skin.


Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes- Time schedule: daily- Cage side observations included: appearance, behaviour, secretory function and dischargesDETAILED CLINICAL OBSERVATIONS: NoDERMAL IRRITATION (if dermal study): Yes- Time schedule for examinations: weekly- Parameters evaluated: erythema and edema according to Draize, chronic deterioration: flaking, thickening, stiffening, cracking and slouthingBODY WEIGHT: Yes - Time schedule for examinations: weeklyFOOD CONSUMPTION:- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: NoFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: NoWATER CONSUMPTION: NoOPHTHALMOSCOPIC EXAMINATION: NoHAEMATOLOGY: Yes- Time schedule for collection of blood: at study termination- Animals fasted: No data- How many animals: all animals- Parameters examined: red blood cells, white blood cells, and plateletsCLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: at study termination- Animals fasted: No data- How many animals: all animals- Parameters examined: glucose, urea nitrogen, alanine aminotransferase, albumin, phosphorus; only females: lactate dehydrogenase, aspartate aminotransferaseURINALYSIS: Yes- Time schedule for collection of urine: weeks 5 and 13- Metabolism cages used for collection of urine: No- Parameters examined: pH, bilirubin, specific gravity, urobilinogen, blood, protein, glucose, ketonesNEUROBEHAVIOURAL EXAMINATION: NoOTHER: sperm morphology: at termination- Parameters: percentage normal sperm, abnormal heads, headless, tailless, and curled tail
Sacrifice and pathology:
GROSS PATHOLOGY: Yes; organ weights: kidneys, liver; only males: brain, spleen; only females: thyroidsHISTOPATHOLOGY: Yes (no further information available)
The level of statistical significance was P < 0.05.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No treatment-related effects were observed.
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
Local effects: Slight erythema and flaking of the skin were observed in the treated groups during the dosing phase. Microscopic examination of the skin indicated trace to slight epidermal hyperplasia and chronic inflammation of the superficial dermis.
no mortality observed
Description (incidence):
No treatment-related effects were observed.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Treated males gained slightly less weight than the controls (800 mg/kg bw: 7%, 2000 mg/kg bw: 10%). As the difference is low, the decrease in body weight was not interpreted as a sign for systemic toxicity.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Description (incidence and severity):
No adverse effects on any haematologic parameters measured were observed.
Clinical biochemistry findings:
effects observed, non-treatment-related
Description (incidence and severity):
A few of the serum parameters of the high-dose animals were statistically different from the controls, but the differences were small, not consistent between males and females, and did not present any pattern suggestive of effects on any specific organ (no corresponding histological findings). Thus, the effects were considered not to be of toxicological relevance. - high-dose males (compared to controls): glucose: -14%, albumin: -3%, and phoshorus: +16%- high-dose females (compared to controls): lactate dehydrogenase: +45% (low-dose: +22%), and aspartate aminotransferase: +22%.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No additional data given on Urinalysis in study report.
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
Increased thyroid weight in the low-dose (+ 25%) females and decreased spleen weight (- 10%) in the low-dose males were not considered to be toxicologically relevant, as these effects were not observed in the high-dose groups.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No abnormalities were detected.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No abnormalities were detected.
Histopathological findings: neoplastic:
no effects observed
Other effects:
no effects observed
Description (incidence and severity):
OTHER FINDINGS- Sperm morphology: No effects on sperm morphology were detected.
Skin penetration values of 2 - 6% were obtained. The results of the in vivo skin penetration study indicate that the 13-week treatment with the test substance does not increase the skin penetration of the test substance (only the value for females was statistically different from the penetration in untreated animals). The skin penetration of untreated rats was less than 2% and the mean value for treated rats was approx. 6%. The recovery of radioactivity was measured in the urine and faeces as well as the remaining radioactivity in tissue samples.

Effect levels

Key result
Dose descriptor:
Effect level:
>= 2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: highest dose tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion