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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Stearic anhydride
EC Number:
211-318-6
EC Name:
Stearic anhydride
Cas Number:
638-08-4
Molecular formula:
C36H70O3
IUPAC Name:
octadecanoic anhydride

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
water
Duration of treatment / exposure:
28 days
Frequency of treatment:
five days per week
No. of animals per sex per dose:
0 (G1, Control), 250 (G2, Low dose), 500 (G3, Intermediate dose) and 1000 (G4, High dose), 0 (G1R, Control recovery) and 1000 (G4, High dose recovery) mg/kg body weight/day. Each group consisted of five males and five females.
Control animals:
yes, concurrent vehicle
Details on study design:
Known weight of the Stearinsaureanhydrid was moistened with minimum volume of distilled water, so as to prepare a paste. The paste thus prepared was evenly applied to the groups of male and females rats by dermal route applied to the skin on a five days per week basis for 4 weeks. Control group of animals were similarly treated but with distilled water alone.

Examinations

Observations and examinations performed and frequency:
The following observations were performed: Mortality/ Viability (Twice daily), Ophthalmoscopy (before start of treatment and towards end of the treatment period), clinical signs (daily), body weights and feed consumption (once weekly), haematology, clinical biochemistry and urine analysis at the end of treatment ( after 4 weeks) and recovery (6 weeks).
At the end of the treatment and recovery period, all animals were weighed, sacrificed and necropsied. Histological examination was performed on all organs and tissues of control and high dose group animals as per the study plan and target organs of low, intermediate as well as in control recovery and high dose recovery groups. Urine samples were collected for analysis and blood was sampled for clinical pathology from all the animals.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No clinical signs of illness were observed in any of the animals during treatment and recovery period.
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Description (incidence):
Mortality was not observed in any of the animals of the different treatment groups during the study.
No clinical signs of illness were observed in any of the animals during treatment and recovery period.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Body weights and Body weights gain of male and female of all the treated animals were comparable with the respective control group animals during dosing period of 28 days and recovery period of 14 days.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
During the 28 consecutive days of dosing period and post -dosing recovery period of 14 days the quantity of feed consumed by animals across different dose groups was found to be comparable with that of respective control animals.
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
no effects observed
Description (incidence and severity):
No abnormalities were observed in the ophthalmological examination conducted during
acclimatization and at the end of treatment in the control and high dose group.
Haematological findings:
effects observed, non-treatment-related
Description (incidence and severity):
No treatment-related effect were detected in the measured hematological parameters of treatment and recovery groups compared with respective control groups.
Clinical biochemistry findings:
effects observed, non-treatment-related
Description (incidence and severity):
No treatment-related effect were detected in the measured biochemistry parameters of treatment and recovery groups compared with respective control groups.
Endocrine findings:
not examined
Urinalysis findings:
no effects observed
Description (incidence and severity):
No treatment-related effect were observed either in the group mean values or in the incidence of semi quantitative observations made across different dose groups.
No test item related changes in the urinary parameters were observed in the treatment and recovery
groups compared with respective control groups.
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):
No test item related changes were observed in absolute, relative organ weights values of male and
female animals during treatment and recovery period.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no treatment related macroscopic findings across different groups of both sexes.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
There were no treatment related microscopic findings across different groups of both sexes.
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
There were no treatment related microscopic findings across different groups of both sexes.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment related effects

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
In the present study, No test item related changes in body weight, body weight gain, clinical signs, ophthalmic examination findings, feed consumption and urine analysis were noted. Minor changes in hematological, clinical biochemistry and organ weights were recorded at the end of treatment and recovery periods. But, the variations observed were considered incidental and the respective tissues revealed no abnormalities in macroscopic and histopathological examination. There were no treatment related systemic effects at any dose level. In the light of above observations, the No Observed Adverse Effect Level (NOAEL) of Stearinsaureanhydrid) for Wistar rats via the dermal route could be considered as >1000 mg/kg body weight under the experimental conditions.