C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1982-08-05 to 1982-08-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because even though it was conducted according to GLP standards, it did not conform to accepted harmonized guidelines, and only two exposure concentrations were used.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

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

Adequacy of study:

supporting study

Study period:

1982-08-05 to 1982-08-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because even though it was conducted according to GLP standards, it did not conform to accepted harmonized guidelines, and only two exposure concentrations were used.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline available

Principles of method if other than guideline:

There are no guidelines for short-term studies with 9 days of exposure

GLP compliance:

yes

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Vehicle:

other: Corn Oil

Duration of treatment / exposure:

6 hours

Remarks:

Doses / Concentrations:
1000 or 2000 mg/kg
Basis:

No. of animals per sex per dose:

5

Control animals:

yes

Critical effects observed:

not specified

Conclusions:

The repeated dermal application of Gulftene 12-16 resulted in histological changes in the skin at the site of application. These changes consisted of hyperplasia and thickening of the epidermis (acanthosis) and hyperkeratosis on the surface of the skin. In the test animals, these changes were often associated with acute dermatitis and focal ulceration of the epidermis.

Executive summary:

In a 9-day dermal toxicity study, Gulftene 12-16 was applied to the shaved skin of 5 Fischer 344 rats per sex per dose at dose levels of 0, 1000, or 2000 mg/kg bw/day, 6 hours per day on 9 non-consecutive days during a 2 week study period.

 

Body weight gains were reduced in the 2000 mg/kg group with the effect more notable in males. Severe dermal reactions occurred in the 2000 mg/kg group starting after the second treatment and continuing throughout the study period. They consisted of severe erythema (i.ebeet redness), slight to moderate eschar formation, very slight to slight edema, and slight to moderate desquamation. Slight to moderate hair loss occurred in nearly all animals after the 8^th treatment and fissuring occurred in 4 of the 5 treated females after the 6^thtreatment. Slight erythema occurred in 3 of the 10 animals exposed to 1000 mg/kg after 6 or 7 treatments, with one animal exhibiting a pinpoint spot of eschar. These changes were histopathologically confirmed. No effects were observed in hematology or clinical chemistry. There were several significant changes in organ weights in the 2000 mg/kg group that were related to the decreased body weights. Histopathology findings were only observed in the skin. NO NOAEL or LOAEL was reported in the study.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because even though it was conducted according to GLP standards, it did not conform to accepted harmonized guidelines, and only two exposure concentrations were used.

This study was selected as a supporting study because it did not conform to accepted harmonized guidelines and only two expsoure contrations were evaluated; however, the study contains relevant and useful information, allowing it to qualify as a supporting study.

 

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

There are no guidelines for short-term studies with 9 days of exposure

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C12-16 alpha olefins

IUPAC Name:

C12-16 alpha olefins

Constituent 2

Reference substance name:

Alkenes, C12-14 α-

EC Number:

292-463-2

EC Name:

Alkenes, C12-14 α-

Cas Number:

90622-61-0

Molecular formula:

C12H24 and C14H28

IUPAC Name:

Alkenes C12-14 α-

Details on test material:

- Name of test material (as cited in study report): Gulftene 12-16
- Substance type: C12-16 alpha olefins

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Vehicle:

other: Corn Oil

Duration of treatment / exposure:

6 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
1000 or 2000 mg/kg
Basis:

No. of animals per sex per dose:

5

Control animals:

yes

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The repeated dermal application of Gulftene 12-16 resulted in histological changes in the skin at the site of application. These changes consisted of hyperplasia and thickening of the epidermis (acanthosis) and hyperkeratosis on the surface of the skin. In the test animals, these changes were often associated with acute dermatitis and focal ulceration of the epidermis.

Executive summary:

In a 9-day dermal toxicity study, Gulftene 12-16 was applied to the shaved skin of 5 Fischer 344 rats per sex per dose at dose levels of 0, 1000, or 2000 mg/kg bw/day, 6 hours per day on 9 non-consecutive days during a 2 week study period.

 

Body weight gains were reduced in the 2000 mg/kg group with the effect more notable in males. Severe dermal reactions occurred in the 2000 mg/kg group starting after the second treatment and continuing throughout the study period. They consisted of severe erythema (i.ebeet redness), slight to moderate eschar formation, very slight to slight edema, and slight to moderate desquamation. Slight to moderate hair loss occurred in nearly all animals after the 8^th treatment and fissuring occurred in 4 of the 5 treated females after the 6^thtreatment. Slight erythema occurred in 3 of the 10 animals exposed to 1000 mg/kg after 6 or 7 treatments, with one animal exhibiting a pinpoint spot of eschar. These changes were histopathologically confirmed. No effects were observed in hematology or clinical chemistry. There were several significant changes in organ weights in the 2000 mg/kg group that were related to the decreased body weights. Histopathology findings were only observed in the skin. NO NOAEL or LOAEL was reported in the study.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because even though it was conducted according to GLP standards, it did not conform to accepted harmonized guidelines, and only two exposure concentrations were used.

This study was selected as a supporting study because it did not conform to accepted harmonized guidelines and only two expsoure contrations were evaluated; however, the study contains relevant and useful information, allowing it to qualify as a supporting study.