Terphenyl, hydrogenated

Endpoint summary

Description of key information

Terphenyl, hydrogenated was very well tolerated in rats after both dermal and ocular testing for irritation and corrosion according to the Draize method. Scores were 0.1 on a scale of 8 for skin irritation and 0.3 on a scale of 110 for eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Isaac's Farm Isf
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 1.91-2.90 kg
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL to each application site

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: one inch square, two sites
- Type of wrap if used: latex rubber

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped
- Time after start of exposure: 24 hours

SCORING SYSTEM: Primary irritation index (Draize procedure)

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24,72 hours

Score:

0.1

Max. score:

8

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24,72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24,72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

Mean PDI = 0.1 on a scale of 8

Executive summary:

A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal exposure of hydrogenated terphenyl to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study appears to be in non-compliance with 21 CFR Part 58 but is appropriate to assess potential eye irritation from ocular contact.

Principles of method if other than guideline:

Draize method

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Isacc's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

6 animals (3 Males and 3 Females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after test material administration

Reading times: 24, 48 and 72 hours

SCORING SYSTEM: Draize score

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0.06

Max. score:

4

Reversibility:

fully reversible within: 48h

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

2

Irritation parameter:

other: Draize score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0.3

Max. score:

110

Reversibility:

fully reversible within: 48h

Interpretation of results:

GHS criteria not met

Conclusions:

Mean Draize socre = 0.3 on a scale of 110

Executive summary:

When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation score for 24, 48 and 72 hours was 0.3 on a scale of 110 in six rabbits. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A key study for skin irritation was performed in rats with Terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. A primary irritation score (mean of 24 and 72h) of 0.1 on a scale of 8.0 was calculated following a 24-hour dermal occlusive exposure of Terphenyl, hydrogenated to the intact and abraded skin of six rabbits. No apparent signs of systemic toxicity were observed. A supporting study was available in rabbits, however the reliability was low (Klimisch score 4) as there were no data on the test material composition. The primary irritation score following a 24-hour dermal exposure to the skin was 2 on a scale of 8.0 (Clarks et al., 1979). Another study was not further considered for safety assessment (Monsanto, IBT study, 1970). IBT studies are considered to be unreliable unless otherwise stated (as documented in the OECD HPV manual).

A key study for eye irritation was performed in rats with terphenyl, hydrogenated (Branch et al., 1980); the study was conducted according to Draize method, and was considered to be reliable, adequate and relevant. When 0.1 mL of undiluted Terphenyl, hydrogenated was instilled into the conjunctival sac of the rabbit eye, the average of the Draize irritation scores for 24, 48 and 72 hours was 0.3 on a scale of 110 for six rabbit eyes. Minor corneal involvement was observed in one eye during the study. All treated eyes had regained a normal appearance by the second day of observation. Another study was available (Monsanto, IBT study, 1970), however it was not taken into account for safety assessment for the same reason as above. 

Justification for classification or non-classification

The endpoint does not meet classification criteria according to EU and/or CLP criteria.