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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EC.B7
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
IUPAC Name:
A mixture of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Fischer 344

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Duration of exposure per day: 6 hours
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 87.5 mg/kg bw/day
Male: 5 animals at 263 mg/kg bw/day
Male: 5 animals at 875 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 87.5 mg/kg bw/day
Female: 5 animals at 263 mg/kg bw/day
Female: 5 animals at 875 mg/kg bw/day

Results and discussion

Results of examinations

Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
Skin irritation was observed starting day 2 in all dose groups. Initial findings included erythema in all dose groups (increasing with dose and time) and oedema in the highest dose group.
Other findings associated with skin irritation were fissures, erosion, crusting and excoriation.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Body weight was reduced (not statistically significant) in both sexes at the highest dose, resulting in a significantly lower body weight gain at each measurement period.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No treatment related effects were observed on food consumption.
Description (incidence and severity):
Changes in haematological parameters (elevation of total leukocytes and number of segmented neutrophils) were probably related to the skin irritation.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Histological evidence of this irritation were hyperkeratosis, acanthosis and spongiosis of the epidermis with inflammation ranging from suppurative to ulcerative.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
0.1 mg/kg bw/day (nominal)
Basis for effect level:
dermal irritation
Dose descriptor:
NOEL
Effect level:
87.5 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
clinical signs

Target system / organ toxicity

Critical effects observed:
yes
Lowest effective dose / conc.:
87.5 mg/kg bw/day (nominal)
System:
other: kidney
Organ:
kidney
Treatment related:
yes

Applicant's summary and conclusion

Conclusions:
The notifier proposed a NOAEL(systemic) of 263 mg/kg bw, however, in view of the effects observed (reduced body weight gain, the dose related effects on kidneys, and the absence of urinalysis) the Dutch CA, during a NONS notification, considers the 87.5 mg/kg bw the NOAEL. The NOAEL for local skin effects is <87.5 mg/kg bw in view of the local effects found.