Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

other: no data

Test material

Test material information

Constituent 1

Reference substance name:

64742-65-0

Cas Number:

64742-65-0

IUPAC Name:

64742-65-0

Constituent 2

Reference substance name:

solvent-dewaxed heavy paraffinic, sufficiently refined, IP 346 < 3%

IUPAC Name:

solvent-dewaxed heavy paraffinic, sufficiently refined, IP 346 < 3%

Test material form:

other: Oily liquid

Details on test material:

- Name of test material (as cited in study report): API 78-10 solvent dewaxed heavy paraffinic Oil
-CAS number: 64742-65-0
- Substance type: Other Lubricant base oil (sufficiently refined, IP 346 < 3%)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

the lubricant base oils were administered undiluted to either the abraded or unabraded skin of 2 male and 2 female New Zealand White rabbits (8 rabbits in total) at doses of either 2000 or 5000 mg/kg. The treated skin was occluded for 24 hours after which time the coverings were removed, and residual test material was wiped from the skin.

Duration of exposure:

24 hours

Doses:

2000 or 5000 mg/kg

No. of animals per sex per dose:

2/sex/dose

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

None

Clinical signs:

other: see Other findings below

Other findings:

The only clinical signs were skin irritation and the occurrence of soft stool in some animals, but this latter effect was transient. Skin irritation ranged from slight to severe for erythema and oedema; slight to marked for atonia, desquamation, and fissuring; and from slight to moderate for coriaceousness.

Body weight:
Body weights were recorded prior to administration of test material and then 7 and 14 days post- administration

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 > 5000 mg/kg bw/day.

Executive summary:

Justification for read across

Treated distillate aromatic extracts (TDAEs) are a further processing of untreated distillate aromatic extracts (UDAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from UDAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across.

In an acute dermal toxicity study, groups of New Zealand white rabbits (2/male and 2/ female) were dermally exposed to lubricant base oil API 78 -10 for 24 hours at doses of 2000 or 5000 mg/kg bw.  Animals then were observed for 14 days.

After 14 days all animals were killed and were subjected to a gross necropsy. There were no mortalities in any of the studies. The only clinical signs were skin irritation and the occurrence of soft stool in some animals, but this latter effect was transient. Skin irritation ranged from slight to severe for erythema and oedema; slight to marked for atonia, desquamation, and fissuring; and from slight to moderate for coriaceousness. The LD₅₀s were greater than the doses that had been applied (i.e.2000 or 5000 mg/kg)

This study is classified as reliable without restriction because it was conducted according to OECD Guideline 402.