Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Endpoint summary

Description of key information

Skin Irritation

Not irritating to the skin

 

Ocular Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

Oct. 2, 1990- Oct. 23, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 2, 1990 To: Oct. 23, 1990

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control area on each test animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted

Duration of treatment / exposure:

4 hrs

Observation period:

21 days

Number of animals:

6 - 3 males, 3 females

Details on study design:

TEST SITE
- Area of exposure: An 8 x 8 cm dorsal area of the trunk was clipped. Part of this area was used as a control.
- % coverage: An approximately 2.5 x 2.5 cm area of the trunk was covered.
- Type of wrap if used: Test material was placed beneath two single layers of surgical gauze which were secured with non-irritating adhesive tape. Trunks of the animals were wrapped with semi-permeable dressing held in place with non-irritating adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with room temperature tap water and wiped with a wet cloth.
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

other: 21 days

Remarks on result:

other: Fully reversible in all but 2 animals (very minor redness observed)

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

All animals showed very slight erythema/eschar at the 3-4 hrs observation. This persisted in all animals until at least day 10, with some animals showing an increase to a score of 2. The erythema/eschar did not resolve in two of the animals by the end of the experiment at day 21. Two animals showed very slight edema at the .75 hr observation, with all animals showing this at the 24 hr observation. The edema symptoms did not worsen, and resolved in all animals by day 21.

Other effects:

No other effects were seen in any animal at any observation.

Animal		Observation
		Hours				Days
		3-4	24	48	72	7	10	14	17	21
9918-M	Erythema/eschar	1	1	1	1	1	0	0	0	0
	Edema	0	1	1	1	1	1	0	0	0
9920-M	Erythema/eschar	1	1	1	1	1	1	1	1	0
	Edema	0	1	1	1	1	1	0	0	0
9922-M	Erythema/eschar	1	1	1	1	1	1	1	1	1
	Edema	1	1	1	1	1	1	0	0	0
9913-F	Erythema/eschar	1	2	2	2	1	1	1	1	0
	Edema	0	1	1	1	1	1	0	0	0
9915-F	Erythema/eschar	1	1	1	1	2	2	1	1	0
	Edema	0	1	1	1	1	1	0	0	0
9917-F	Erythema/eschar	1	1	1	2	2	2	1	1	1
	Edema	1	1	1	1	1	1	1	1	0

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

This study examined the skin irritancy of MR Solvent to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

Oct. 1, 1990 - Oct. 4, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990

Vehicle:

unchanged (no vehicle)

Controls:

other: the non-treated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.

Observation period (in vivo):

72 hrs at which time no animals showed signs of irritation.

Number of animals or in vitro replicates:

9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure


SCORING SYSTEM: According to EPA guidelines 81-4


TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

other: unwashed eyes

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: unwashed eyes

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: unwashed eyes

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: unwashed eyes

Irritant / corrosive response data:

All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.

Other effects:

No other effects were observed in any animal at any observation.

Individual Eye Irritation Scores - Washed

Animal		1 hr	24 hrs	48 hrs	72 hrs
9960-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	0	0	0	0
	Conjunctiva, discharge	0	0	0	0
9962-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	0	0	0	0
	Conjunctiva, discharge	0	0	0	0
9964-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	0	0	0	0
	Conjunctiva, discharge	0	0	0	0

Individual Eye Irritation Scores - Unwashed

Animal		1 hr	24 hrs	48 hrs	72 hrs
9954-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	1	0	0	0
	Conjunctiva, discharge	0	0	0	0
9956-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	0	0	0	0
	Conjunctiva, discharge	0	0	0	0
9958-M	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	0	0	0	0
	Conjunctiva, discharge	0	0	0	0
9957-F	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	1	0	0	0
	Conjunctiva, discharge	0	0	0	0
9959-F	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	1	0	0	0
	Conjunctiva, discharge	0	0	0	0
9961-F	Cornea, opacity	0	0	0	0
	Cornea, area	0	0	0	0
	Iris	0	0	0	0
	Conjunctiva, redness	1	1	0	0
	Conjunctiva, chemosis	1	0	0	0
	Conjunctiva, discharge	0	0	0	0

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0.  The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation.  Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is no data available for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, data is available for structural analogue, C9-C14 Aliphatic Solvents (2 -25% aromatics). This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Skin Irritation

 

C9-C14 Aliphatic Solvents (2-25% aromatics)

A key study (Sasol, 1990a) examined the skin irritancy of C9-C14 aliphatic solvents (2-25% aromatics) to rabbit skin. 3 male and 3 female rabbits were exposed dermally to 0.5 ml of test substance for 4 hrs. Test substance was applied to a clipped dorsal area and the area occluded. After 4 hrs, the test areas were washed with tap water. Once the test substance was removed, the animals were scored for skin irritation. Additional observations were made at 24, 48, and 72 hrs, and 7, 10, 14, 17, and 21 days after removal. Animals exhibited very slight erythema and edema (score of 1) beginning at the first observation. By the 24 hr observation, some of the erythema scores had risen to 2, which reversed by day 10. All edema symptoms had resolved by day 21, however, two animals still had very slight redness on day 21. No other signs of skin irritation were seen. The average erythema score was calculated using the scores from the 24, 48, and 72 hr observations was 1.22 and the average edema score was calculated as 1.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation

 

C9-C14 Aliphatic Solvents (2-25% aromatics)

In a key eye irritation study (Sasol, 1990b), application of 0.1ml of C9-C14 aliphatic solvents (2-25% aromatics) to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) does not meet the criteria for classification for skin Irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation:

Based on available read across data, Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) does not meet the criteria for classification as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Respiratory Irritation:

There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).