Fatty acids, tall-oil, magnesium salts

Endpoint summary

Description of key information

The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance.

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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read-across, see attached file.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0,5 ml of test substance

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 hours after patch removal.

Number of animals:

3

Irritation parameter:

erythema score

Time point:

other: 1 h

Score:

0

Irritation parameter:

erythema score

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Time point:

other: 1h

Score:

0

Irritation parameter:

edema score

Time point:

24/48/72 h

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Mean Scores.:
Erythema / Eschar: 0,0 for all 3 animals
Oedema: 0,0 for all 3 animals

Executive summary:

Aim of the study

The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 2004/73/EC, method B.4.

Administration of the test substance

0.5 mL "CRUDE TALL OIL" was applied via a patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours.

First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.

Investigations

• Body weights: at the start and at the termination of the test.

• General signs of toxicity: once daily.

• Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).

Results

General signs of toxicity

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations

• Erythema/Eschar: Not affected.

• Oedema: Not affected.

Residual test substance was noted on the exposed skin areas, resp. on the growing hair, until 72 h p.a.

Conclusion

The following mean scores were calculated for each animal from the examinations 24 h,  48 h and 72 h p.a.:

Mean Scores.:

• Erythema / Eschar: 0,0 for all 3 animals
• Oedema: 0,0 for all 3 animals

According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for skin irritation

Reference 2

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: GLP Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 -5 month
- Weight at study initiation: 2.8 - 2.9 kg
- Housing: single housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen; Altromin GmbH Lage/Lippe
- Water (e.g. ad libitum): Tab water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h, test substance was removed by washing with warm tab water at the end of the exposure period

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72

Score:

0.66

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: eshar formation was still visible

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks:

7 days

Irritant / corrosive response data:

Edema score was 0 at day 7 but raised to a grade 1 in one animal and grade 2 in another animal at day 14. Erythema and eshar formaton was still visible after 14 days. Because edema was gone at day 7 and returned afterwards it may concluded that scratching occurred. The over all assumption is that ethylhexanoic acid is only slightly irritating.

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

See justification for read across in the attached file

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Results from Tall oil

Irritation parameter:

edema score

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Results from Tall oil

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: 2-EHA

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2-EHA

Interpretation of results:

GHS criteria not met

Executive summary:

According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for skin irritation, however 2 -ethylhexanoic acid is slightly irritant to skin.

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:

experimental study

Adequacy of study:

key study

Study period:

26 September 2005 - 7 October 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read-across, see attached file.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1, 24, 48 and 72 hours p.a

Number of animals or in vitro replicates:

3 females

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

other: Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

The mean irritation parameters are 0,0 in scoring for all parametres. However, the scoring for the first hour for all animals is 1 except for chemosis where one out of three had scoring 0,0. Redness in the Conjunctivae area were associated with discharge with moistening of the lids and hairs just adjacent to the lids.

No signs of irritation was seen after 1h.

Interpretation of results:

GHS criteria not met

Executive summary:

Aim of the study

The aim of this study was to investigate possible irritating or corrosive effects of the pure test substance following a single administration into a conjunctival sac of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD-Guideline 405 and the Directive 2004/73/EC, method B.5.

Administration of the test substance

0.1 mL of "CRUDE TALL OIL" was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Firstly the test substance was administered to one animal. As there was no corrosive or severe irritant effect observed, the test substance was administered to two additional animals one week later.

Investigations

• Body weights: at the start and at the termination of the test.

• General signs of toxicity: once daily.

• Eye examinations: 1, 24, 48 and 72 h after the administration (p.a.) of the test substance.

Results

General signs of toxicity

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Eye examinations

• Corneae and Irises: Not affected.  
• Conjunctivae, redness: Some injected blood vessels (score "1") were observed in all animals only 1 h p.a.
• Conjunctivae, chemosis: Very slight swelling (score "1") was observed in 2/3 animals only 1 h p.a.
• Additional findings: Ocular discharge was noted in all animals 1 h p.a.

Conclusion

The mean scores were calculated for each animal was 0,0 from the examinations 24 h,  48 h and 72 h p.a.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

See attached file for justification for read across.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Tall oil

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Tall oil

Irritation parameter:

other: Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Tall oil

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Tall oil

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: 2-EHA

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2-EHA

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2-EHA

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.89

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 2-EHA

Interpretation of results:

GHS criteria not met

Executive summary:

The conclusions from read-across shows that the UVCB substance will not be classified according to CLP.

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline conforme GLP Study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: single housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen; Altromin GmbH Lage/Lippe
- Water (e.g. ad libitum): Tab water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 µL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
no

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.56

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 -72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.89

Max. score:

4

Reversibility:

fully reversible within: 7 days

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Based on the available information, the substance was not observed to be irritating in eyes or skin in animal models. There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for selection of skin irritation / corrosion endpoint: OECD & EC guideline study, no deviations, GLP 

Justification for selection of eye irritation endpoint: OECD & EC guideline study, no deviations, GLP

Justification for classification or non-classification

According to the study results on crude tall oil and2 -ethylhexanoic acid the substance requires no clasification, because the results are not sufficient for classification.