Naphthalene-2,6-dicarboxylic acid

Endpoint summary

Description of key information

A skin irritation/corrosion study and an eye irritation study revealed no adverse effects.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Remarks:

saline solution

Amount / concentration applied:

0.5 g/kg

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

3

Details on study design:

- Method of administration: applied to moistened shaved backs
- After removal of the test item, the site was washed with saline solution

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0.2

Interpretation of results:

GHS criteria not met

Conclusions:

The test item revealed slight skin irritation during the study. The primary dermal irritation score was 0.2. The test item has not to be classified as dermal or eye irritant according to Regulation (EC) No 1272/2008.

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

Study period:

March 26, 1981 (Animal Receipt) to May 22, 1981 (Final Report)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

At the time the study was performed, it followed Proposed Guidelines for Registering Pesticides in te US; Haard Evaluation: Humans and Domestic Animals. Primary Irritation Study. 40 CFR Part 163.81-4

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

At the time the study was performed, the guideline had not been officially accepted (i.e., Proposed Guideline)

Deviations:

no

GLP compliance:

no

Remarks:

Study was performed before USEPA GLP guidelines. Study was fully documented and followed SOPs and published literature

Specific details on test material used for the study:

Very fine white powder, supplied by Celanese corporation. Storage at room temperature.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand White albino rabbits were obtained from Penn Dutch Laboratory Animls in Denver, Pennsylvania, USA. Nine animals were received as young adults weighing between 2.3 and 3.2 kg. The animlas were acclimated for 18 days before treatment.

All animlas were checked for viability twice daily during the equilibration period. Prior to assignment to study, all animals were examined to ascertain suitability for study. Rabbits were individually housed in suspended, stainless steeel, cages. Temperature as monitored twice daily, and ranged from 63-66 degrees farenheight. Humidity was also monitored daily and the animals were on a 12 hr light, 12 hr dark light cycle. Food was Purina Rabbit Chow, fed ad libitum. Animals were provided municipal water (Elizabethtown Water Co.) ad libitum via automatic watering system. Animls were identified with a monel ear tag bearing a unique number.

Amount / concentration applied:

0.1 cc of the test material was introduced into the lower conjuctival sac of the right eye of each animal.

Duration of treatment / exposure:

The upper and lower eye lids were held together for one second prior to relasing to prevent loss of material. The contralateral eye served as the control. The treated and control eyes of six animals remained unwashed. Twenty seconds after the test substance was administered, both eyes of the remaining three animals were rinsed for one minute with lukewarm water.

Observation period (in vivo):

Animlals were were checked twice daily, for general signs of toxicity. They eyes were checked at intervals of approximately 24, 48, and 72 hours and 4 and 7 days after treatment. If there were no signs of irritaiton on Day 7, no aditional observations were made.

Details on study design:

At each interval the treated and control eyes were examined and scored for occular reactions according to the Draize scale. Fluorescein dye was used to confirm the presence or absence of corneal ulceration in treated eyes starting wtih the 24 hour observation and at each subsequent observation until there was no stain retention for two observations. Unusual effects, such as pannus, blistering of the conjunctiva, ulceration and other effects indicative of corrosive action were also noted when present.

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: 48 hr

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hr

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: 48

Irritation parameter:

overall irritation score

Basis:

animal #4

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hr

Irritation parameter:

overall irritation score

Basis:

animal #5

Time point:

24 h

Score:

0

Irritation parameter:

overall irritation score

Basis:

animal #6

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: 48

Irritation parameter:

overall irritation score

Basis:

animal: 7

Remarks:

washed eye

Time point:

24 h

Score:

0

Irritation parameter:

overall irritation score

Basis:

animal: 8, washed eye

Time point:

24 h

Score:

2

Reversibility:

fully reversible within: 48 hr

Irritation parameter:

overall irritation score

Basis:

animal: 9, washed eye

Time point:

24 h

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Only slight signs of conjunctival redness and/or chemosis at 24 and 48 hrs

Executive summary:

The only signs of occular irritation were slight conjunctival redness and/or chemosis at 24 and/or 48 hrs in five of six animals with unwashed eyes and in one of three animals with washed eyes. Three animals showed no evidence of ocular irritation. No positive scores were exhibited by any animal and all animals were free of signs of ocular irritation within 72 hrs after administration of 2,4-naphthalene dicarboxylic acid.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Based on the results of the skin irritation and eye irritation studies, the test item has not to be classified as dermal or eye irritant according to Regulation (EC) No 1272/2008.