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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Klimisch code 1 (reliable without restriction)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
See category justification attached in Section 13 for more information. Evaluating alkyl phenate sulfides (“phenates”) as a category is appropriate based on similar chemical structures and starting materials, manufacturing processes, physical and chemical properties, functional uses as a lubricating oil additive, and toxicological data. Regarding the ECHA Read-Across Assessment Framework (2017), the alkyl phenate category fit into Scenario 6 (different compounds with the same effect and no variation in the strength of that effect across substances).

Phenates in this category are manufactured in a similar way and from the same staring alkylphenol, tetrapropenyl phenol (“TPP”, EC 310-154-3; AKA phenol, dodecyl-, branched (PDB, PDDP)). The primary difference among the phenates is if they have calcium carbonate basing; the amount of overbasing may also differ. However, based on the trends observed with the robust toxicology data for the category, the amount of calcium carbonate overbasing is not expected to alter the hazards, especially as the core phenate functionality does not change and calcium carbonate has a low hazard potential.

Based on the data and consistent trends observed among category members, phenates have low hazard for human health and the environment. The registered (target) substance, EC 701-208-0 is very similar to EC 701-251-5 and this substance can be used as direct read across (and is used as the test material in the target record, where data exists for this source substance); EC 701-249-4 and 272-388-1 serve to bracket EC 701-208-0 with EC 701-251-5 regarding different levels of calcium carbonate overbasing.
Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
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 specified
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 250 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: 250 mg/kg/bw/day was highest dose tested. No LOAEL was determined.
Critical effects observed:
no
Conclusions:
Repeat dose toxicity through the dermal route is not expected based on analog data.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch code 1 (reliable without restriction)

Additional information

Justification for classification or non-classification

Based on no adverse effects observed in a well-conducted 90 day study with an analog substance, which is consistent with data from the category, the classification criteria for target organ toxicity are not met. This is also consistent with no adverse effects in the key 28 -day dermal toxicity study.