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Administrative data

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 701-249-4) is very similar to EC 701-251-5 except that it lacks the calcium carbonate overbasing. Therefore, EC 701-251-5 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 272-388-1 (no calcium hydroxide added) brackets EC 701-249-4 with EC 701-251-5 regarding different levels of calcium carbonate overbasing.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenol, paraalkylation products with C10-15 branched olefins (C12 rich) derived from propene oligomerization, carbonates, calcium salts, overbased, sulfurized including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
EC Number:
701-251-5
Molecular formula:
Formula for a representative structure is C36H58Ca2O4Sx where x = 1,2. Actual molecular formula is not possible to generate. Substance is a UVCB.
IUPAC Name:
Phenol, paraalkylation products with C10-15 branched olefins (C12 rich) derived from propene oligomerization, carbonates, calcium salts, overbased, sulfurized including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
Test material form:
liquid: viscous
Details on test material:
- Name and of test material (as cited in study report): Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased
- CAS number of test material (as cited in study report): 68784-26-9
- Physical state: Dark brown viscous liquid
- Other: The test substance was assumed to be 100% active ingredient. Stability and purity data were the responsibility of the sponsor.

Results and discussion

Results of examinations

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

Effect levels

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.

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Repeat dose toxicity through the dermal route is not expected based on analog data.